FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ENDOPATH REUSABLE CANNULA 5MM, 75MM LER
MDR report key: 402759
·
Received June 28, 2002
Report
- Report Number
- 1527736-2002-01247
- Event Type
- Malfunction
- Date Received
- June 28, 2002
- Report Date
- April 1, 2002
- Manufacturer
- ETHICON ENDO-SURGERY, INC.(TORRES)
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTEDLY THAT A DEVICE WAS USED DURING A LAP CHOLECYSTECTOMY. THE DEVICE BROKE IN HALF AND FELL INTO THE PT. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ENDOPATH REUSABLE CANNULA 5MM, 75MM LER | ENDOPATH RESPOSABLE TROCAR SYSTEM | GCJ | ETHICON ENDO-SURGERY, INC.(TORRES) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |