FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH DISPOSABLE SURGICAL TROCAR
MDR report key: 217987
·
Received April 6, 1999
Report
- Report Number
- 1527736-1999-01976
- Event Type
- Malfunction
- Date Received
- April 6, 1999
- Date of Event
- March 11, 1999
- Report Date
- March 12, 1999
- Manufacturer
- ETHICON ENDO-SURGERY, INC. S.A. DE C.V.
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE REP THAT DURING THE PROCEDURE, THE SURGEON NOTICED THE TROCAR WAS LEAKING. AFTER INSPECTION, THE OUTER GASKET WAS FOUND TO BE TORN. IN ADDITION, THE SURGEON NOTICED THAT THE PLASTIC BASE AROUND THE OUTER GASKET WAS LOOSE. NEITHER SURGEON HAD NEVER SEEN SUCH A LOOSE PIECE IN THE TROCAR. THERE WAS NO CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH DISPOSABLE SURGICAL TROCAR | TROCARS | GCJ | ETHICON ENDO-SURGERY, INC. S.A. DE C.V. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |