FDA Adverse Event
Injury
Summary report: N
LIGAMAX 5
MDR report key: 1639110
·
Received March 19, 2010
Report
- Report Number
- MW5015247
- Event Type
- Injury
- Date Received
- March 19, 2010
- Date of Event
- March 8, 2010
- Report Date
- March 19, 2010
- Manufacturer
- CQ LABS
- Product Code
- GDO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE APPLIER BROKE. THE JAW WOULD NOT CLOSE AND IT WOULD NOT APPLY A CLIP PROPERLY. THIS OCCURRED AFTER CLIPPING VESSELS. THERE WAS NO PT INJURY AND THE CASE CONTINUED AS NORMAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX 5 | ENDOSCOPIC APPLIER | GDO | CQ LABS | EL5ML | GSR80L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Disability |