Devices › Unit, electrosurgical, endoscopic (with or without accessories)
Device brand name · Unit electrosurgical endoscopic with or without accessories
Rezum: medical device reports filed with FDA
1,479 reports name it, 2019–2026. Manufacturer given most often on reports: Boston Scientific. Product code KNS.
- 1,479
- device reports naming the brand
- 0% of all MAUDE reports · about 197 a year
- 524
- reports, 12 months to August 2026
- 235 in the 12 months before
- 27.9%
- classified as malfunction
- 77.6% across the product code
- 0.9%
- classified as death, as reported
- 13 reports · not verified by FDA
1,479 medical device reports received by FDA name the brand "Rezum" (unit electrosurgical endoscopic with or without accessories); the manufacturer given most often on reports is Boston Scientific; received from January 2019 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
524 reports arrived in the 12 months to August 2026, up 123% from 235 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 injury (71.3%), malfunction (27.9%) and death (0.9%); 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 defective device (5.3%), material integrity problem (3.9%) and retraction problem (3.5%). The patient problems coded most often are urinary retention, urinary tract infection and hematuria. 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 |
|---|---|---|---|
| Defective devicethe device was defective | 79 | 5.3% | 0.5% |
| Material integrity problema problem with the device material | 58 | 3.9% | 0.6% |
| Retraction problem | 52 | 3.5% | 2.2% |
| Pressure problem | 50 | 3.4% | 0.1% |
| Device contamination with chemical or other material | 48 | 3.2% | 0.6% |
| Device displays incorrect message | 43 | 2.9% | 0.9% |
| Temperature problem | 21 | 1.4% | 0.1% |
| Mechanical problema mechanical problem | 20 | 1.4% | 0.7% |
| Power problem | 20 | 1.4% | 0% |
| Insufficient device problem information | 17 | 1.1% | 0.5% |
| Communication or transmission problemthe device could not communicate or transmit | 16 | 1.1% | 0.1% |
| Gas output problem | 15 | 1% | 0.1% |
| Nonstandard device | 14 | 0.9% | 0.1% |
| No display/image | 11 | 0.7% | 0% |
| Breakthe device broke | 8 | 0.5% | 28.5% |
| Device contaminated during manufacture or shipping | 8 | 0.5% | 0.4% |
| Impedance problem | 8 | 0.5% | 0% |
| Material fragmentation | 6 | 0.4% | 0.5% |
| Failure to prime | 5 | 0.3% | 0% |
| Problem with sterilization | 5 | 0.3% | 0% |
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 |
|---|---|---|
| Urinary retentionbeing unable to empty the bladder | 330 | 22.3% |
| Urinary tract infectionbladder or urinary infection | 261 | 17.6% |
| Hematuria | 249 | 16.8% |
| Painpain, site not specified | 158 | 10.7% |
| Micturition urgency | 155 | 10.5% |
| Dysuriapain on passing urine | 133 | 9% |
| Hemorrhage/blood loss/bleeding | 101 | 6.8% |
| Inflammationinflammation | 93 | 6.3% |
| Urinary frequency / polyuria | 92 | 6.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 60 | 4.1% |
| Urinary incontinenceleaking urine | 60 | 4.1% |
| Fever | 53 | 3.6% |
| Sexual dysfunctiona sexual problem | 41 | 2.8% |
| Sepsisa severe body-wide response to infection | 38 | 2.6% |
| Discomfortdiscomfort | 37 | 2.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Rezum | Product code KNS | All MAUDE reports |
|---|---|---|---|
| Reports | 1,479 | 17,476 | 26,136,888 |
| Share of that pool | — | 8.5% | 0% |
| Classified as death, per 1,000 reports | 9 | 5 | 9 |
| Classified as injury | 71.3% | 20.9% | 36.2% |
| Classified as malfunction | 27.9% | 77.6% | 62.3% |
| Filed by the manufacturer | 99.5% | 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% |
| 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 Rezum reports
How many FDA reports name Rezum?
1,479 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 524 in the latest 12 months.
What kinds of events are reported?
injury (71.3%), malfunction (27.9%) and death (0.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
defective device (5.3%), material integrity problem (3.9%), retraction problem (3.5%), pressure problem (3.4%) and device contamination with chemical or other material (3.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%) and voluntary reports (0.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Rezum 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.