Devices › Unit, electrosurgical, endoscopic (with or without accessories)
Device brand name · Single use 2-lumen sphincterotome
Single Use 3-Lumen Sphincterotome V: medical device reports filed with FDA
1,767 reports name it, 2012–2026. Manufacturer given most often on reports: Aomori Olympus. Product code KNS.
- 1,767
- device reports naming the brand
- 0% of all MAUDE reports · about 126 a year
- 256
- reports, 12 months to August 2026
- 331 in the 12 months before
- 95.7%
- classified as malfunction
- 77.6% across the product code
- 0.2%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 1,767 reports that name the brand "Single Use 3-Lumen Sphincterotome V" (single use 2-lumen sphincterotome), received between July 2012 and August 2026; the manufacturer given most often on reports is Aomori Olympus. Spellings of one product vary from report to report.
256 reports arrived in the 12 months to August 2026, down 23% from 331 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 (95.7%), injury (3.8%) and other (0.3%); 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 break (86%), material split, cut or torn (7.1%) and peeled/delaminated (3.5%). The patient problems coded most often are hemorrhage/blood loss/bleeding, pancreatitis and perforation. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
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 |
|---|---|---|---|
| Breakthe device broke | 1,520 | 86% | 28.5% |
| Material split, cut or torn | 125 | 7.1% | 1.1% |
| Peeled/delaminated | 61 | 3.5% | 1.6% |
| Melted | 59 | 3.3% | 0.9% |
| Detachment of device or device componentpart of the device came off | 33 | 1.9% | 3.2% |
| Material fragmentation | 25 | 1.4% | 0.5% |
| Sparking | 21 | 1.2% | 0.5% |
| Thermal decomposition of device | 15 | 0.8% | 0.5% |
| Material separation | 12 | 0.7% | 3.2% |
| Material twisted/bent | 12 | 0.7% | 0.9% |
| Mechanical problema mechanical problem | 5 | 0.3% | 0.7% |
| Device handling problem | 4 | 0.2% | 0.1% |
| Material deformation | 4 | 0.2% | 1.7% |
| Device dislodged or dislocated | 3 | 0.2% | 0.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 3 | 0.2% | 0.9% |
| Fracturea broken bone | 3 | 0.2% | 0.6% |
| Unintended movement | 3 | 0.2% | 0.1% |
| Contamination /decontamination problem | 2 | 0.1% | 0% |
| Device damaged prior to usethe device was damaged before use | 2 | 0.1% | 0.2% |
| Electrical /electronic property probleman electrical or electronic problem | 2 | 0.1% | 1.2% |
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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 21 | 1.2% |
| Pancreatitisinflammation of the pancreas | 18 | 1% |
| Perforation | 12 | 0.7% |
| Foreign body in patientpart of a device left in the patient | 6 | 0.3% |
| Hemostasis | 6 | 0.3% |
| Burn(s)a burn | 5 | 0.3% |
| Cholangitis | 5 | 0.3% |
| Tissue damage | 4 | 0.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 3 | 0.2% |
| Peritonitis | 3 | 0.2% |
| Bowel perforation | 2 | 0.1% |
| Electric shockan electric shock | 2 | 0.1% |
| Gastrointestinal hemorrhage | 2 | 0.1% |
| Inflammationinflammation | 2 | 0.1% |
| Perforation of esophagus | 2 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Single Use 3-Lumen Sphincterotome V | Product code KNS | All MAUDE reports |
|---|---|---|---|
| Reports | 1,767 | 17,476 | 26,136,888 |
| Share of that pool | — | 10.1% | 0% |
| Classified as death, per 1,000 reports | 2 | 5 | 9 |
| Classified as injury | 3.8% | 20.9% | 36.2% |
| Classified as malfunction | 95.7% | 77.6% | 62.3% |
| Filed by the manufacturer | 99.7% | 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 |
|---|---|---|---|
| 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% |
| Hydratome Rx Sphincterotome | 458 | 0 | 0.2% |
| 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 Single Use 3-Lumen Sphincterotome V reports
How many FDA reports name Single Use 3-Lumen Sphincterotome V?
1,767 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 256 in the latest 12 months.
What kinds of events are reported?
malfunction (95.7%), injury (3.8%) and other (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (86%), material split, cut or torn (7.1%), peeled/delaminated (3.5%), melted (3.3%) and detachment of device or device component (1.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) and distributor reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Single Use 3-Lumen Sphincterotome V 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.