FDA Adverse Event
Other
Summary report: N
ETHICON ENDO-SURGERY, INC.
MDR report key: 262151
·
Received February 11, 2000
Report
- Report Number
- 262151
- Event Type
- Other
- Date Received
- February 11, 2000
- Date of Event
- February 7, 2000
- Report Date
- February 10, 2000
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- KNF
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- WV, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SCISSORS WOULD NOT CUT. SEEMED SHARP ON ENDS, BUT DULL TO CUT. DID NOT CLOSE PROPERLY. CHEWED UP BILE DUCT AND PHYSICIAN UNABLE TO PERFORM CHOLANGIOGRAM. IF STONE IS IN BILE DUCT COULD CAUSE LATER PROBLEMS. BECAUSE OF INABILITY TO PERFORM A CHOLANGIOGRAM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON ENDO-SURGERY, INC. | 5MM CURVED SCISSORS WITH MONOPOLAR CAUTERY | KNF | ETHICON ENDO-SURGERY, INC. | M4FD8W | CE 0123 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other |