Devices › Unit, electrosurgical, endoscopic (with or without accessories)
Device brand name · Unit electrosurgical endoscopic with or without accessories
Hydratome Rx Sphincterotome: medical device reports filed with FDA
458 reports name it, 2007–2011. Manufacturer given most often on reports: Boston Scientific. Product code KNS.
- 458
- device reports naming the brand
- 0% of all MAUDE reports · about 24 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 96.7%
- classified as malfunction
- 77.6% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
458 medical device reports received by FDA name the brand "Hydratome Rx Sphincterotome" (unit electrosurgical endoscopic with or without accessories); the manufacturer given most often on reports is Boston Scientific; received from July 2007 to August 2011. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (96.7%), injury (3.1%) and death (0.2%); across all unit, electrosurgical, endoscopic (with or without accessories) reports (product code KNS) death is recorded in 0.5% and malfunction in 77.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are other (for use when an appropriate device code cannot be identified) (21%), break (14.8%) and bent (9.2%). The patient problems coded most often are no patient involvement, brain injury and therapy/non-surgical treatment, additional. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Hydratome Rx Sphincterotome was received in the five years to August 2026; the latest was received in August 2011.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 17,476 reports carrying product code KNS. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Other (for use when an appropriate device code cannot be identified) | 96 | 21% | 2.3% |
| Breakthe device broke | 68 | 14.8% | 28.5% |
| Bent | 42 | 9.2% | 1.4% |
| Wire(s), breakage of | 38 | 8.3% | 1.2% |
| Component(s), broken | 27 | 5.9% | 1% |
| Tip breakage | 25 | 5.5% | 1.6% |
| Split | 15 | 3.3% | 0.4% |
| Detachment of device component | 13 | 2.8% | 2.5% |
| Crackthe device cracked | 11 | 2.4% | 0.3% |
| Device damaged prior to usethe device was damaged before use | 11 | 2.4% | 0.2% |
| Kinkedthe tube or line kinked | 11 | 2.4% | 0.5% |
| Material frayed | 11 | 2.4% | 0.4% |
| Failure to cut | 9 | 2% | 1% |
| Peeled/delaminated | 8 | 1.7% | 1.6% |
| Device contamination with chemical or other material | 6 | 1.3% | 0.6% |
| Electrical /electronic property probleman electrical or electronic problem | 5 | 1.1% | 1.2% |
| Failure to advance | 5 | 1.1% | 0.2% |
| Leak/splashthe device leaked | 4 | 0.9% | 0.1% |
| Melted | 4 | 0.9% | 0.9% |
| Tears, rips, holes in device, device material | 3 | 0.7% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| No patient involvement | 10 | 2.2% |
| Brain injury | 4 | 0.9% |
| Therapy/non-surgical treatment, additional | 4 | 0.9% |
| Bleeding | 3 | 0.7% |
| Hospitalization required | 3 | 0.7% |
| Other (for use when an appropriate patient code cannot be identified) | 2 | 0.4% |
| Therapy/non-surgical treatment, aborted/stopped | 2 | 0.4% |
| Therapy/non-surgical treatment/delayed/prolonged | 2 | 0.4% |
| Cut(s) | 1 | 0.2% |
| Deaththe patient died; cause not stated by this term | 1 | 0.2% |
| Improved patient condition | 1 | 0.2% |
| Microperforation(s) | 1 | 0.2% |
| Nonresorbable materials, unretrieved in body | 1 | 0.2% |
| Perforation | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Hydratome Rx Sphincterotome | Product code KNS | All MAUDE reports |
|---|---|---|---|
| Reports | 458 | 17,476 | 26,136,888 |
| Share of that pool | — | 2.6% | 0% |
| Classified as death, per 1,000 reports | 2 | 5 | 9 |
| Classified as injury | 3.1% | 20.9% | 36.2% |
| Classified as malfunction | 96.7% | 77.6% | 62.3% |
| Filed by the manufacturer | 100% | 96.3% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code KNS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Single Use 3-Lumen Sphincterotome V | 1,767 | 256 | 0.2% |
| Rezum | 1,479 | 524 | 0.9% |
| Single Use Electrosurgical Knife | 920 | 52 | 0.5% |
| Injection Gold Probe | 582 | 12 | 0.2% |
| Fusion Omni-Tome Pre-Loaded Sphincterotome | 502 | 0 | 0% |
| Autotome RX 44 | 481 | 62 | 0.2% |
| Fusion Omni-Tome | 452 | 15 | 0% |
| Autotome Rx Sphincterotome | 441 | 0 | 0.5% |
| Dreamtome RX 44 | 441 | 34 | 0.5% |
| TRUEtome 44 | 394 | 80 | 0% |
| Hydratome RX 44 | 298 | 10 | 0% |
| Tri-Tome Pc Triple Lumen Sphincterotome | 254 | 0 | 0% |
| Endostat 3 Bipolar/Monopolar Electrosurgical Generator | 237 | 0 | 0% |
| Axios? | 582 | 224 | 1.5% |
| Gold Probe | 236 | 15 | 0% |
Ordered by report count for navigation only. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Hydratome Rx Sphincterotome reports
How many FDA reports name Hydratome Rx Sphincterotome?
458 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (96.7%), injury (3.1%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
other (for use when an appropriate device code cannot be identified) (21%), break (14.8%), bent (9.2%), wire(s), breakage of (8.3%) and component(s), broken (5.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Hydratome Rx Sphincterotome was at fault?
No. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.