FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH, 7/8 MM
MDR report key: 12864
·
Received April 20, 1994
Report
- Report Number
- MW1001673
- Event Type
- Malfunction
- Date Received
- April 20, 1994
- Date of Event
- March 31, 1994
- Report Date
- April 8, 1994
- Manufacturer
- ETHICON ENDO-SURGERY
- Product Code
- KDC
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MS, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING THE PERFORMANCE OF A BILATERAL TUBAL LIGATION USING A LAPAROSCOPE, TWO TROCARS FROM TWO MFRS CHIPPED, LEAVING SMALL FRAGMENTS IN THE PERITONEAL CAVITY. (ALSO SEE 1001672.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH, 7/8 MM | KDC | ETHICON ENDO-SURGERY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR |