FDA Adverse Event
Malfunction
Summary report: N
LIGASURE LAPAROSCOPIC SLR/DIV
MDR report key: 1053543
·
Received May 28, 2008
Report
- Report Number
- 1717344-2008-00220
- Event Type
- Malfunction
- Date Received
- May 28, 2008
- Date of Event
- March 28, 2008
- Report Date
- April 30, 2008
- Manufacturer
- COVIDIEN LP (US SURGICAL)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE OF INITIAL REPORT: THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE REPORT STATED THAT THE LIGASURE ATLAS WAS IN USE DURING A SIGMOIDECTOMY WHEN A THREAD OR CABLE BEGAN SHOWING ON THE DEVICE. A VISUAL EXAMINATION OF THE RETURNED DEVICE IN 2008, FOUND THAT ONE OF THE WIRES THAT LEAD TO THE JAWS OF THE DEVICE HAS BARE METAL WIRE SHOWING THROUGH THE INSULATION.
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) | N8A242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |