FDA Adverse Event
Malfunction
Summary report: N
RESOLUTION CLIP CLIPPING DEVICE
MDR report key: 24904655
·
Received April 16, 2026
Report
- Report Number
- 3005099803-2026-01400
- Event Type
- Malfunction
- Date Received
- April 16, 2026
- Date of Event
- March 25, 2026
- Report Date
- May 18, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PKL
- UDI-DI
- 08714729504818
- PMA / PMN Number
- K222503
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
BLOCK 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 CLIP WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE CLIP WOULD NOT DEPLOY THEN FELL OFF CATHETER WHILE REMOVING FROM SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 60976 | RESOLUTION CLIP CLIPPING DEVICE | CLIP, HEMOSTATIC | PKL | BOSTON SCIENTIFIC CORPORATION | M00522612 | 0037714209 | 08714729504818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |