FDA Adverse Event
Malfunction
Summary report: N
LIGASURE V SEALER/DIVIDER
MDR report key: 2212105
·
Received July 8, 2011
Report
- Report Number
- 1717344-2011-00541
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- May 19, 2011
- Report Date
- June 17, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE HAS BEEN REQUESTED, BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED 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 THE DEVICE WILL NOT SEAL AND THAT THE JAWS WERE DIFFICULT TO OPEN DURING THE PROCEDURE. NO FURTHER INFO WAS MADE AVAILABLE BY THE SITE. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE V SEALER/DIVIDER | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 204409X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Life Threatening |