FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
MDR report key: 285143
·
Received July 5, 2000
Report
- Report Number
- 1527736-2000-02975
- Event Type
- Malfunction
- Date Received
- July 5, 2000
- Date of Event
- June 10, 2000
- Report Date
- June 16, 2000
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GDO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE AFFILIATE THAT THE(1) ER420 WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT CLIP WOULD NOT FEED INTO THE JAW PROPERLY. THE CASE WAS COMPLETED WITH ANOTHER DEVICE AND WITH NO PT CONSEQUENCE.
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. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |