FDA Adverse Event
Malfunction
Summary report: N
RADIAL JAW 3 BIOPSY FORCEPS
MDR report key: 1191186
·
Received September 25, 2008
Report
- Report Number
- 3005099803-2008-04831
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- August 26, 2008
- Report Date
- August 26, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FCL
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE FACILITY. THE CAUSE OF THE EVENT IS UNDETERMINED.
Description of Event or Problem · 1
DURING THE COLONOSCOPY PROCEDURE, RADIAL JAW 3 BIOPSY FORCEPS WAS USED. THE FITTING WAS LOOSE ON THE FORCEPS AND IT WOULD NOT ALLOW THE DEVICE TO BECOME HOT. THIS HAPPENED TWICE USING TWO DIFFERENT RADIAL JAW 3 BIOPSY FORCEPS. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A THIRD OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS AND THE PATIENT IS FINE. THIS IS COMPLAINT 1 OF 2. REFER TO ASSOCIATED MANUFACTURER REPORT # 3005099803-2008-04832 FOR A DESCRIPTION OF THE FIRST EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIAL JAW 3 BIOPSY FORCEPS | FCL | BOSTON SCIENTIFIC CORPORATION | M00515503 | 0011509343 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |