FDA Adverse Event
Malfunction
Summary report: N
RADIAL JAW 4
MDR report key: 20969020
·
Received December 18, 2024
Report
- Report Number
- 3005099803-2024-06470
- Event Type
- Malfunction
- Date Received
- December 18, 2024
- Date of Event
- November 29, 2024
- Report Date
- December 18, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- BWH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF JAWS FAILURE TO CLOSE.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 PULMONARY BIOPSY FORCEPS WAS USED IN A BRONCHIAL FIBROSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE JAWS OF THE BIOPSY FORCEPS FAILED TO CLOSE. ANOTHER FORCEPS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2022792 | RADIAL JAW 4 | FORCEPS, BIOPSY, BRONCHOSCOPE (NON-RIGID) | BWH | BOSTON SCIENTIFIC CORPORATION | M00515181 | 0034003364 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |