FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
MDR report key: 242749
·
Received September 30, 1999
Report
- Report Number
- 1527736-1999-05141
- Event Type
- Malfunction
- Date Received
- September 30, 1999
- Date of Event
- September 8, 1999
- Manufacturer
- ETHICON ENDO-SURGERY, INC., S.A. DE C.V.
- Product Code
- GDO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT (1) DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE AFFILIATE THAT THE ER320 CLIP DIDN'T FEED INTO THE JAWS, BUT ABOVE THE JAWS. THIS DEVICE WAS COLLECTED BY THE HOSPITAL AND RETURNED ALONG WITH EES#100979 AND 100980.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER | CLIP APPLIER | GDO | ETHICON ENDO-SURGERY, INC., S.A. DE C.V. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |