FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP ENDOSCOPIC SINGLE CLIP APPLIER
MDR report key: 202333
·
Received December 15, 1998
Report
- Report Number
- 1527736-1998-04207
- Event Type
- Malfunction
- Date Received
- December 15, 1998
- Date of Event
- September 18, 1998
- Report Date
- November 23, 1998
- Manufacturer
- POST SURGICAL MFG.
- Product Code
- GDO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT AN EL414 WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE AFFILIATE THAT THE INSTRUMENT DROPS THE CLIPS INSIDE THE PTS BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP ENDOSCOPIC SINGLE CLIP APPLIER | CLIP APPLIERS - ENDOSCOPIC/REUSABLE | GDO | POST SURGICAL MFG. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |