FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH DILATING TIP TROCAR
MDR report key: 217809
·
Received April 5, 1999
Report
- Report Number
- 1527736-1999-01945
- Event Type
- Malfunction
- Date Received
- April 5, 1999
- Report Date
- March 9, 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
- IA, US
- Reporter Occupation
- NURSE
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 BOTH DIAPHRAGM ON THE 511SD AND THE ONE SEAL TORE CAUSING LOSS OF PNEUMO. THE CASE WAS COMPLETED WITH AN ADD'L 511SD AND ONE SEAL. THERE WAS NO CONSEQUENCE TO THE PT.
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 |