FDA Adverse Event
Malfunction
Summary report: N
RESOLUTION 360 CLIP
MDR report key: 23789153
·
Received December 12, 2025
Report
- Report Number
- 3005099803-2025-06694
- Event Type
- Malfunction
- Date Received
- December 12, 2025
- Date of Event
- November 19, 2025
- Report Date
- December 12, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PKL
- UDI-DI
- 08714729875628
- PMA / PMN Number
- K222503
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H6: IMDRF DEVICE CODE A150208 CAPTURES THE REPORTABLE EVENT OF CLIP DEVICE DEPLOYED IN SCOPE.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION 360 CLIP WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CLIP DEPLOYED INSIDE THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2781548 | RESOLUTION 360 CLIP | HEMOSTATIC METAL CLIP FOR THE GI TRACT | PKL | BOSTON SCIENTIFIC CORPORATION | M00521230 | 0036805760 | 08714729875628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |