Boston Scientific - Spencer medical device reports that give this manufacturer
- Name type
- Device manufacturer, as written on reports
What a report is
A report is not proof that the device was the cause of the event.
FDA says:
Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Device Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .
FDA also says:
Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use.
Source: openFDA, Device Adverse Event Overview. The site read the page on .
MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .
Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.
Reports on file
From April 2009 to November 2018, FDA received 10,997 medical device reports that give Boston Scientific - Spencer as the manufacturer. A manufacturer name is as written on the report, so a subsidiary or a different spelling can be a separate name.
FDA received 0 reports in the 12 months to September 2026 and 0 in the 12 months before. FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.
Manufacturer reports were 100% of the reports that name this manufacturer and 94.9% of all device reports.
The number of people who use the product is not in the data. A count is not a rate.
Why manufacturers report
FDA says:
Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices.
Source: FDA Center for Devices and Radiological Health, Medical Device Reporting (MDR): How to Report Medical Device Problems. Content current as of . The site read the page on .
Data version
openFDA MAUDE release of 23 Oct 2026. Reports received through 30 Sep 2026.
Brand names
The table has the 44 brand pages with 5 or more reports that give this manufacturer. The rows are in order of name. A brand page with fewer reports is not in the table.
FDA says:
MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
| Brand name | Product code | Reports | Reports, 12 months to September 2026 |
|---|---|---|---|
| Advanix Biliary | Stents, drains and dilators for the biliary ducts | 250 | 68 |
| Advanix? Pancreatic Stent | Stents, drains and dilators for the biliary ducts | 68 | 18 |
| Advantage Fit System | Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator | 13 | 9 |
| Autotome RX 44 | Unit, electrosurgical, endoscopic (with or without accessories) | 73 | 60 |
| Autotome Rx Sphincterotome | Unit, electrosurgical, endoscopic (with or without accessories) | 137 | 0 |
| Biliary Stent Biliary Stent System Biliary Endoprosthesis | Stents, drains and dilators for the biliary ducts | 318 | 0 |
| Bone Anchor System For Soft Tissue Support | Fastener, fixation, nondegradable, soft tissue | 248 | 0 |
| Dreamtome RX 44 | Unit, electrosurgical, endoscopic (with or without accessories) | 76 | 30 |
| Endovive Initial Placement Peg Kit Direct Pej Kit And Peg Safety Kit | Tubes, gastrointestinal (and accessories) | 297 | 0 |
| Endovive Jejunal Feeding Tube | Tubes, gastrointestinal (and accessories) | 307 | 0 |
| EndoVive Safety PEG Kit | Tubes, gastrointestinal (and accessories) | 280 | 23 |
| Endovive Securi-T | Tubes, gastrointestinal (and accessories) | 120 | 0 |
| EndoVive Standard PEG Kit | Tubes, gastrointestinal (and accessories) | 288 | 15 |
| Endovive Two-Port Ttp Jejunal Feeding Tube Cap | Tubes, gastrointestinal (and accessories) | 230 | 0 |
| Flexima Biliary | Stents, drains and dilators for the biliary ducts | 235 | 32 |
| Flexima Catheter | Tube, drainage, suprapubic | 62 | 0 |
| Flexima Plus Biliary | Stents, drains and dilators for the biliary ducts | 10 | 23 |
| Gemini | Dislodger, stone, basket, ureteral, metal | 39 | 11 |
| Genesys Hta Procerva | Device, thermal ablation, endometrial | 139 | 0 |
| Hydratome RX 44 | Unit, electrosurgical, endoscopic (with or without accessories) | 99 | 8 |
| Hydratome Rx Sphincterotome | Unit, electrosurgical, endoscopic (with or without accessories) | 141 | 0 |
| Interject | Biopsy needle | 197 | 7 |
| Jagtome RX 44 | Unit, electrosurgical, endoscopic (with or without accessories) | 20 | 17 |
| Jagtome Rx Sphincterotome | Unit, electrosurgical, endoscopic (with or without accessories) | 32 | 0 |
| Leveen Coaccess | Electrosurgical, cutting & coagulation & accessories | 86 | 0 |
| Leveen Needle Electrode | Electrosurgical, cutting & coagulation & accessories | 62 | 0 |
| NaviFlex? RX Delivery System | Stents, drains and dilators for the biliary ducts | 28 | 22 |
| Navigator Hd | Endoscopic access overtube, gastroenterology-urology | 53 | 1 |
| Prefyx Pps System | Mesh, surgical, polymeric | 461 | 0 |
| Rx Biliary | Stents, drains and dilators for the biliary ducts | 119 | 5 |
| RX Cytology Brush | Endoscopic cytology brush | 255 | 5 |
| RX Locking Device and Biopsy Cap | 59 | 10 | |
| RX Needle Knife XL | Unit, electrosurgical, endoscopic (with or without accessories) | 15 | 14 |
| Solyx SIS System | Mesh, surgical, polymeric | 14 | 6 |
| Speedband Superview Super 7 | Ligator, esophageal | 1,266 | 594 |
| Spyscope Ds Access & Delivery Catheter | Choledochoscope and accessories, flexible/rigid | 692 | 0 |
| Stonetome | Dislodger, stone, biliary | 61 | 22 |
| Trapezoid RX | Lithotriptor, biliary mechanical | 532 | 125 |
| Trapezoid Rx Lithotripter Compatible Basket Models 1086 1087 1088 | Lithotriptor, biliary mechanical | 176 | 0 |
| TRUEtome 44 | Unit, electrosurgical, endoscopic (with or without accessories) | 15 | 82 |
| Ultratome XL | Snare, flexible | 19 | 33 |
| Uphold Lite | Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed | 39 | 0 |
| Zero Tip | Dislodger, stone, basket, ureteral, metal | 127 | 39 |
| Zero Tip Nitinol Stone Retrieval Basket | Dislodger, stone, basket, ureteral, metal | 61 | 0 |
Device types
The table has the 21 device types with 5 or more reports that give this manufacturer. The rows are in order of name.
FDA says:
MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
Reports by month
FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.
Event type
| Event type | Reports | Share | Share as a bar |
|---|---|---|---|
| Death | 51 | 0.5% | |
| Injury | 2,936 | 26.7% | |
| Malfunction | 8,006 | 72.8% | |
| Other | 0 | 0% | |
| Not given | 4 | under 0.1% |
The event type is the classification that the reporter gave. FDA does not verify it.
Official pages
- Medical Device Reporting (MDR): How to Report Medical Device ProblemsThe FDA page that tells how to report a problem with a medical device.
- MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
- Manufacturer and User Facility Device Experience (MAUDE) DatabaseThe search page of FDA for the device reports.
The site checked these addresses on . The links open in a new tab.
Cite this page
Reported Reactions. Boston Scientific - Spencer: medical device reports that give this manufacturer. https://reportedreactions.com/manufacturer/boston-scientific-spencer/ Source: U.S. Food and Drug Administration, openFDA Device Adverse Event (MAUDE) files, release of . Reports received through .
Where the data come from
The counts come from the openFDA Device Adverse Event (MAUDE) bulk files, release of 23 Oct 2026. The files have the reports that FDA received through 30 Sep 2026. Brand names, generic names and manufacturer names are as written on the reports. The names of the product codes come from the device classification of FDA.
The site removes company suffixes (Inc., LLC, GmbH and similar) before it counts a manufacturer name. A name that reads as a person and not as an organisation is not published. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.
Questions
Does a large count say something about the manufacturer?
Not by itself. FDA says:
MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.
Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .
What event types do the reports record?
Death (51), injury (2,936) and malfunction (8,006). The event type is the classification that the reporter gave. FDA does not verify it.
Why can one company have more than one page?
The manufacturer field is free text on the report. This page counts the 10,997 reports with the name Boston Scientific - Spencer after the site removes company suffixes. A subsidiary, a plant or a different spelling is a separate name.