FDA Adverse Event
Malfunction
Summary report: N
ENDO PATH
MDR report key: 90809
·
Received May 8, 1997
Report
- Report Number
- 90809
- Event Type
- Malfunction
- Date Received
- May 8, 1997
- Date of Event
- April 10, 1997
- Report Date
- April 28, 1997
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
DURING LAP CHOLE - THE "O" RING FROM TROCAR FELL INTO THE ABDOMEN. DR. RETRIEVED "O" RING FROM PTS ABD. CAVITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO PATH | DISPOSABLE SURGICAL TROCHAR | GCJ | ETHICON ENDO-SURGERY, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |