FDA Adverse Event
Malfunction
Summary report: N
RADIAL JAW 3 BIOPSY FORCEPS
MDR report key: 1191221
·
Received September 25, 2008
Report
- Report Number
- 3005099803-2008-04861
- Event Type
- Malfunction
- Date Received
- September 25, 2008
- Date of Event
- August 22, 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
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING THE ENDOSCOPIC PROCEDURE IN COLON, THE PHYSICIAN WAS UNABLE TO ADVANCE FORCEPS THROUGH PEDIATRIC COLONOSCOPE. THE SAME PROBLEM OCCURRED WITH THE SECOND DEVICE. A THIRD OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PT'S CONDITION IS REPORTED TO BE FINE. THIS IS DEVICE 1 OF 2. REFER TO ASSOCIATED MFR REPORT # 3005099803-2008-04860 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 | M00515372 | 0009583736 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |