Device brand name · Endoscope and/or accessories
Resolution Clip Clipping Device: medical device reports filed with FDA
2,382 reports name it, 2010–2026. Manufacturer given most often on reports: Boston Scientific - Marlborough.
- 2,382
- device reports naming the brand
- 0% of all MAUDE reports · about 145 a year
- 28
- reports, 12 months to August 2026
- 23 in the 12 months before
- 93.7%
- classified as malfunction
- 62.3% across all reports
- 0.1%
- classified as death, as reported
- 3 reports · not verified by FDA
2,382 medical device reports received by FDA name the brand "Resolution Clip Clipping Device" (endoscope and/or accessories); the manufacturer given most often on reports is Boston Scientific - Marlborough; received from February 2010 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
28 reports arrived in the 12 months to August 2026, up 22% from 23 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 (93.7%), injury (6.2%) and death (0.1%). Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are activation, positioning or separation problem (70.9%), separation failure (21.8%) and material deformation (2%). The patient problems coded most often are blood loss, hemorrhage/blood loss/bleeding 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 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Activation, positioning or separation problem | 1,688 | 70.9% |
| Separation failure | 520 | 21.8% |
| Material deformation | 47 | 2% |
| Torn material | 34 | 1.4% |
| Breakthe device broke | 25 | 1% |
| Premature activation | 21 | 0.9% |
| Device contamination with chemical or other material | 20 | 0.8% |
| Difficult to open or close | 18 | 0.8% |
| Human-device interface problem | 11 | 0.5% |
| Bent | 9 | 0.4% |
| Detachment of device component | 9 | 0.4% |
| Failure to advance | 8 | 0.3% |
| Detachment of device or device componentpart of the device came off | 7 | 0.3% |
| Entrapment of device | 5 | 0.2% |
| Failure to disconnect | 5 | 0.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 4 | 0.2% |
| Difficult to advance | 4 | 0.2% |
| Positioning failure | 4 | 0.2% |
| Deformation due to compressive stress | 2 | 0.1% |
| Device packaging compromised | 2 | 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 |
|---|---|---|
| Blood loss | 28 | 1.2% |
| Hemorrhage/blood loss/bleeding | 28 | 1.2% |
| No patient involvement | 23 | 1% |
| Painpain, site not specified | 5 | 0.2% |
| Device embedded in tissue or plaque | 4 | 0.2% |
| Hemostasis | 4 | 0.2% |
| Obstruction/occlusion | 4 | 0.2% |
| Perforation | 4 | 0.2% |
| Abdominal distention | 3 | 0.1% |
| Asthmaasthma | 3 | 0.1% |
| Deaththe patient died; cause not stated by this term | 3 | 0.1% |
| Reactiona reaction, type not specified | 3 | 0.1% |
| Tissue damage | 3 | 0.1% |
| Hypersensitivity/allergic reaction | 2 | 0.1% |
| Nauseafeeling sick | 2 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Resolution Clip Clipping Device | All MAUDE reports |
|---|---|---|
| Reports | 2,382 | 26,136,888 |
| Share of that pool | — | 0% |
| Classified as death, per 1,000 reports | 1 | 9 |
| Classified as injury | 6.2% | 36.2% |
| Classified as malfunction | 93.7% | 62.3% |
| Filed by the manufacturer | 100% | 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."
Questions about Resolution Clip Clipping Device reports
How many FDA reports name Resolution Clip Clipping Device?
2,382 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 28 in the latest 12 months.
What kinds of events are reported?
malfunction (93.7%), injury (6.2%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
activation, positioning or separation problem (70.9%), separation failure (21.8%), material deformation (2%), torn material (1.4%) and break (1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Resolution Clip Clipping Device 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.