FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH DILATING TIP TROCAR
MDR report key: 197423
·
Received November 13, 1998
Report
- Report Number
- 1527736-1998-03535
- Event Type
- Malfunction
- Date Received
- November 13, 1998
- Report Date
- October 16, 1998
- 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
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE REP THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE TROCAR ARM WOULD NOT ENGAGE. 11/04/1998 ANOTHER TROCAR WAS USED TO CONTINUE WITH THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH DILATING TIP TROCAR | TROCARS | GCJ | ETHICON ENDO-SURGERY, INC. S.A DE C.V. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |