Devices › Unit, electrosurgical, endoscopic (with or without accessories)
Device brand name · Kns unit electrosurgical endoscopic with or without accessories
Fusion Omni-Tome Pre-Loaded Sphincterotome: medical device reports filed with FDA
502 reports name it, 2010–2022. Manufacturer given most often on reports: Wilson-Cook Medical. Product code KNS.
- 502
- device reports naming the brand
- 0% of all MAUDE reports · about 32 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 98.4%
- classified as malfunction
- 77.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
502 medical device reports received by FDA name the brand "Fusion Omni-Tome Pre-Loaded Sphincterotome" (kns unit electrosurgical endoscopic with or without accessories); the manufacturer given most often on reports is Wilson-Cook Medical; received from September 2010 to September 2022. 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 (98.4%) and injury (1.6%); 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 failure to align (28.3%), material separation (13.7%) and malposition of device (11%). The patient problems coded most often are foreign body in patient, device embedded in tissue or plaque and no patient involvement. 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 |
|---|---|---|---|
| Failure to align | 142 | 28.3% | 4.5% |
| Material separation | 69 | 13.7% | 3.2% |
| Malposition of device | 55 | 11% | 1.4% |
| Positioning problem | 42 | 8.4% | 1.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 35 | 7% | 0.9% |
| Bent | 29 | 5.8% | 1.4% |
| Migration or expulsion of device | 26 | 5.2% | 0.3% |
| Breakthe device broke | 22 | 4.4% | 28.5% |
| Material twisted/bent | 21 | 4.2% | 0.9% |
| Detachment of device component | 14 | 2.8% | 2.5% |
| Disconnection | 14 | 2.8% | 0.4% |
| Image orientation incorrect | 13 | 2.6% | 0.1% |
| Peeled/delaminated | 10 | 2% | 1.6% |
| Difficult to advance | 7 | 1.4% | 0.5% |
| Device or device fragments location unknown | 5 | 1% | 0.2% |
| Device slipped | 5 | 1% | 0.1% |
| Material protrusion/extrusion | 5 | 1% | 0.1% |
| Device dislodged or dislocated | 4 | 0.8% | 0.8% |
| Material deformation | 4 | 0.8% | 1.7% |
| Material integrity problema problem with the device material | 4 | 0.8% | 0.6% |
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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 10 | 2% |
| Device embedded in tissue or plaque | 5 | 1% |
| No patient involvement | 2 | 0.4% |
| Bowel perforation | 1 | 0.2% |
| Edemaswelling from fluid | 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 | Fusion Omni-Tome Pre-Loaded Sphincterotome | Product code KNS | All MAUDE reports |
|---|---|---|---|
| Reports | 502 | 17,476 | 26,136,888 |
| Share of that pool | — | 2.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 5 | 9 |
| Classified as injury | 1.6% | 20.9% | 36.2% |
| Classified as malfunction | 98.4% | 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% |
| 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 Fusion Omni-Tome Pre-Loaded Sphincterotome reports
How many FDA reports name Fusion Omni-Tome Pre-Loaded Sphincterotome?
502 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 (98.4%) and injury (1.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to align (28.3%), material separation (13.7%), malposition of device (11%), positioning problem (8.4%) and device operates differently than expected (7%). 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 Fusion Omni-Tome Pre-Loaded 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.