FDA Adverse Event
Malfunction
Summary report: N
LIGASURE LAPAROSCOPIC SLR/DIV
MDR report key: 1122263
·
Received August 12, 2008
Report
- Report Number
- 1717344-2008-00369
- Event Type
- Malfunction
- Date Received
- August 12, 2008
- Date of Event
- July 16, 2008
- Report Date
- July 16, 2008
- Manufacturer
- COVIDIEN LP (US SURGICAL)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE REPORT STATED THAT DURING A LAVH WHEN SEALING AND CUTTING BROAD LIGAMENT, AFTER THE SEALING CYCLE WAS COMPLETE AND THE TISSUE CUT, THE INSTRUMENT JAWS WOULD NOT OPEN. THAT PORTION OF TISSUE WAS RESECTED USING BIPOLAR AND THE DEVICE WAS REMOVED. THERE WAS NO BLEEDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE LAPAROSCOPIC SLR/DIV | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (US SURGICAL) | N6J351 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |