FDA Adverse Event
Malfunction
Summary report: N
CAPIO SLIM
MDR report key: 21422564
·
Received February 20, 2025
Report
- Report Number
- 2124215-2025-06378
- Event Type
- Malfunction
- Date Received
- February 20, 2025
- Date of Event
- December 19, 2024
- Report Date
- February 20, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PWI
- UDI-DI
- 08714729842224
- PMA / PMN Number
- K172060
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: DEVICE CODE A050502 CAPTURES THE REPORTABLE EVENT OF A MISFIRED DEVICE.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A PROCEDURE USING A CAPIO SLIM, THE DEVICE MISFIRED. NO PATIENT COMPLICATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464561 | CAPIO SLIM | SPECIALIZED SURGICAL INSTRUMENTATION FOR USE WITH UROGYNECOLOGIC SURGICAL MESH | PWI | BOSTON SCIENTIFIC CORPORATION | M0068318261 | 0034735150 | 08714729842224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Female |