FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH DISPOSABLE SURGICAL TROCAR
MDR report key: 205597
·
Received January 8, 1999
Report
- Report Number
- 1527736-1999-00109
- Event Type
- Malfunction
- Date Received
- January 8, 1999
- Report Date
- December 10, 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
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A TK12M TROCAR KTI WAS USED DURING A LAPAROSCOPIC GALL BLADDER. IT WAS REPORTED BY THE AFFILIATE THAT THE INSTRUMENTS HAVE TORN GASKETS. THERE WAS NO CONSEQUENCE TO THE PT.
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 |