Devices › Hemostatic metal clip for the gi tract
Device brand name · Clip hemostatic
Resolution Clip: medical device reports filed with FDA
884 reports name it, 2008–2026. Manufacturer given most often on reports: Boston Scientific. Product code PKL.
- 884
- device reports naming the brand
- 0% of all MAUDE reports · about 48 a year
- 36
- reports, 12 months to August 2026
- 53 in the 12 months before
- 98.3%
- classified as malfunction
- 90.9% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
884 medical device reports received by FDA name the brand "Resolution Clip" (clip hemostatic); the manufacturer given most often on reports is Boston Scientific; received from February 2008 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
36 reports arrived in the 12 months to August 2026, down 32% from 53 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 (98.3%), injury (1%) and death (0.1%); across all hemostatic metal clip for the gi tract reports (product code PKL) death is recorded in 0.3% and malfunction in 90.9%. 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 (80.2%), difficult to open or close (10%) and premature activation (7.6%). The patient problems coded most often are hemorrhage/blood loss/bleeding, discomfort and swelling/ edema. 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 7,243 reports carrying product code PKL. 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 |
|---|---|---|---|
| Activation, positioning or separation problem | 709 | 80.2% | 52.8% |
| Difficult to open or close | 88 | 10% | 13.6% |
| Premature activation | 67 | 7.6% | 7.1% |
| Material deformation | 45 | 5.1% | 1.6% |
| Breakthe device broke | 29 | 3.3% | 5.8% |
| Material twisted/bent | 26 | 2.9% | 1.4% |
| Positioning failure | 26 | 2.9% | 1.7% |
| Entrapment of device | 13 | 1.5% | 1.5% |
| Human-device interface problem | 13 | 1.5% | 1.7% |
| Failure to advance | 11 | 1.2% | 0.9% |
| Detachment of device or device componentpart of the device came off | 9 | 1% | 2.8% |
| Difficult or delayed positioning | 8 | 0.9% | 0% |
| Defective devicethe device was defective | 4 | 0.5% | 0.4% |
| Difficult to advance | 4 | 0.5% | 0.3% |
| Misfire | 4 | 0.5% | 0.2% |
| Device inoperablethe device could not be used | 3 | 0.3% | 0% |
| Component(s), broken | 2 | 0.2% | 0% |
| Detachment of device component | 2 | 0.2% | 0.2% |
| Failure to deliverthe device did not deliver the dose or item | 2 | 0.2% | 0.1% |
| Other (for use when an appropriate device code cannot be identified) | 2 | 0.2% | 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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 18 | 2% |
| Discomfortdiscomfort | 2 | 0.2% |
| Swelling/ edema | 2 | 0.2% |
| Abdominal painstomach or belly pain | 1 | 0.1% |
| Anemialow red blood cells | 1 | 0.1% |
| Dizzinesslight-headedness or unsteadiness | 1 | 0.1% |
| Foreign body, removal of | 1 | 0.1% |
| No patient involvement | 1 | 0.1% |
| Nonresorbable materials, unretrieved in body | 1 | 0.1% |
| Pancreatitisinflammation of the pancreas | 1 | 0.1% |
| Perforation | 1 | 0.1% |
| Stroke/cva | 1 | 0.1% |
| Syncope/fainting | 1 | 0.1% |
| Ulcer | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Resolution Clip | Product code PKL | All MAUDE reports |
|---|---|---|---|
| Reports | 884 | 7,243 | 26,136,888 |
| Share of that pool | — | 12.2% | 0% |
| Classified as death, per 1,000 reports | 1 | 3 | 9 |
| Classified as injury | 1% | 8.7% | 36.2% |
| Classified as malfunction | 98.3% | 90.9% | 62.3% |
| Filed by the manufacturer | 93.6% | 93.9% | 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 PKL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Resolution 360 Clip | 2,957 | 385 | 0.2% |
| Instinct Plus Endoscopic Clipping Device | 1,225 | 229 | 0% |
| Resolution 360 ULTRA Clip | 608 | 116 | 1% |
| Instinct Endoscopic Hemoclip | 784 | 0 | 0.1% |
| Single Use Repositionable Clip | 275 | 0 | 0% |
| Mantis | 173 | 33 | 0.6% |
| Resolution Clip Clipping Device | 2,382 | 28 | 0.1% |
| Instinct | 1,215 | 1,171 | 0% |
| 6 Shooter Saeed Multi-Band Ligator | 1,440 | 92 | 0.1% |
| Boston Scientific | 580 | 5 | 3.3% |
| Hemospray Endoscopic Hemostat | 1,052 | 116 | 0.9% |
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 Resolution Clip reports
How many FDA reports name Resolution Clip?
884 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 36 in the latest 12 months.
What kinds of events are reported?
malfunction (98.3%), injury (1%) 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 (80.2%), difficult to open or close (10%), premature activation (7.6%), material deformation (5.1%) and break (3.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (93.6%) and voluntary reports (2.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Resolution Clip 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.