FDA Adverse Event
Malfunction
Summary report: N
LIGASURE V SEALER/DIVIDER
MDR report key: 2231329
·
Received July 25, 2011
Report
- Report Number
- 1717344-2011-00583
- Event Type
- Malfunction
- Date Received
- July 25, 2011
- Date of Event
- June 30, 2011
- Report Date
- July 3, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. 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 CUSTOMER REPORTED THAT AFTER SURGERY, IT WAS NOTED THAT THE WHITE INSULATION ON THE JAW OF THE DEVICE WAS CHIPPED. THE LOCATION OF THE MATERIAL IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE V SEALER/DIVIDER | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |