FDA Adverse Event
Malfunction
Summary report: N
LIGASURE PRECISE
MDR report key: 2023748
·
Received February 15, 2011
Report
- Report Number
- 1717344-2011-00102
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- January 18, 2011
- Report Date
- January 18, 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 EVALUATION. 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 BLUE PARTICLES FROM THE DEVICE JAW WERE FOUND ON PT TISSUE DURING THE PROCEDURE. ANOTHER DEVICE WAS USED WITH THE SAME ISSUE. THE ADD'L DEVICE CAN BE FOUND ON MFR. REPORT# 1717344-2011-00103.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE PRECISE | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 192011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |