FDA Adverse Event
Malfunction
Summary report: N
LIGASURE PRECISE
MDR report key: 1983224
·
Received February 2, 2011
Report
- Report Number
- 1717344-2011-00082
- Event Type
- Malfunction
- Date Received
- February 2, 2011
- Date of Event
- January 11, 2011
- Report Date
- January 11, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN REC'D FOR EVAL. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS REC'D OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING USE IN COAGULATION MODE, A SMALL PLASTIC PIECE FROM THE JAW DETACHED AND MELTED ON THE PT'S TISSUE. THE PLASTIC PIECE WAS RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE PRECISE | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 189295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |