FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ATLAS HANDSWITCHING 37CM
MDR report key: 1082435
·
Received July 21, 2008
Report
- Report Number
- 1717344-2008-00337
- Event Type
- Malfunction
- Date Received
- July 21, 2008
- Date of Event
- June 24, 2008
- Report Date
- June 24, 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
THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. 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 USE THE WIRE INSULATION BECAME TORN AND THE BARE WIRE WAS EXPOSED. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE ATLAS HANDSWITCHING 37CM | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (US SURGICAL) | U7A44K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |