Devices › Hemostatic metal clip for the gi tract
Device brand name · Hemostatic metal clip for the gi tract
Resolution 360 Clip: medical device reports filed with FDA
2,957 reports name it, 2016–2026. Manufacturer given most often on reports: Boston Scientific. Product code PKL.
- 2,957
- device reports naming the brand
- 0% of all MAUDE reports · about 289 a year
- 385
- reports, 12 months to August 2026
- 423 in the 12 months before
- 95.9%
- classified as malfunction
- 90.9% across the product code
- 0.2%
- classified as death, as reported
- 6 reports · not verified by FDA
2,957 medical device reports received by FDA name the brand "Resolution 360 Clip" (hemostatic metal clip for the gi tract); the manufacturer given most often on reports is Boston Scientific; received from April 2016 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
385 reports arrived in the 12 months to August 2026, close to the 423 of 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 (95.9%), injury (3.9%) and death (0.2%); 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 (84.3%), break (8%) and difficult to open or close (6%). The patient problems coded most often are hemorrhage/blood loss/bleeding, foreign body in patient 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 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 | 2,494 | 84.3% | 52.8% |
| Breakthe device broke | 238 | 8% | 5.8% |
| Difficult to open or close | 176 | 6% | 13.6% |
| Premature activation | 172 | 5.8% | 7.1% |
| Detachment of device or device componentpart of the device came off | 81 | 2.7% | 2.8% |
| Human-device interface problem | 81 | 2.7% | 1.7% |
| Entrapment of device | 78 | 2.6% | 1.5% |
| Material deformation | 57 | 1.9% | 1.6% |
| Positioning failure | 53 | 1.8% | 1.7% |
| Material twisted/bent | 41 | 1.4% | 1.4% |
| Problem with sterilization | 17 | 0.6% | 0.2% |
| Difficult to advance | 12 | 0.4% | 0.3% |
| Defective devicethe device was defective | 11 | 0.4% | 0.4% |
| Device dislodged or dislocated | 11 | 0.4% | 0.3% |
| Difficult to removethe device was hard to remove | 10 | 0.3% | 0.6% |
| Material separation | 10 | 0.3% | 9.3% |
| Detachment of device component | 9 | 0.3% | 0.2% |
| Material integrity problema problem with the device material | 9 | 0.3% | 0.2% |
| Mechanical problema mechanical problem | 7 | 0.2% | 0.5% |
| Activation failure | 6 | 0.2% | 0.5% |
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 | 82 | 2.8% |
| Foreign body in patientpart of a device left in the patient | 13 | 0.4% |
| Perforation | 6 | 0.2% |
| Laceration(s) | 3 | 0.1% |
| No patient involvement | 3 | 0.1% |
| Tissue damage | 3 | 0.1% |
| Deaththe patient died; cause not stated by this term | 2 | 0.1% |
| Device embedded in tissue or plaque | 2 | 0.1% |
| Discomfortdiscomfort | 2 | 0.1% |
| Hematomaa collection of blood under the skin or in tissue | 2 | 0.1% |
| Abdominal painstomach or belly pain | 1 | 0% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0% |
| Blood loss | 1 | 0% |
| Hypersensitivity/allergic reaction | 1 | 0% |
| Inflammationinflammation | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Resolution 360 Clip | Product code PKL | All MAUDE reports |
|---|---|---|---|
| Reports | 2,957 | 7,243 | 26,136,888 |
| Share of that pool | — | 40.8% | 0% |
| Classified as death, per 1,000 reports | 2 | 3 | 9 |
| Classified as injury | 3.9% | 8.7% | 36.2% |
| Classified as malfunction | 95.9% | 90.9% | 62.3% |
| Filed by the manufacturer | 95.1% | 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 |
|---|---|---|---|
| Instinct Plus Endoscopic Clipping Device | 1,225 | 229 | 0% |
| Resolution Clip | 884 | 36 | 0.1% |
| 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 360 Clip reports
How many FDA reports name Resolution 360 Clip?
2,957 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 385 in the latest 12 months.
What kinds of events are reported?
malfunction (95.9%), injury (3.9%) and death (0.2%). "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 (84.3%), break (8%), difficult to open or close (6%), premature activation (5.8%) and detachment of device or device component (2.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (95.1%) and voluntary reports (1.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Resolution 360 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.