FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 2082663
·
Received April 28, 2011
Report
- Report Number
- 1717344-2011-00319
- Event Type
- Malfunction
- Date Received
- April 28, 2011
- Report Date
- April 25, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE 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 DURING A VAGINAL HYSTERECTOMY, THE DEVICE JAWS BECAME LOCKED ON TISSUE. THE DEVICE WAS CUT FROM TISSUE IN ORDER TO REMOVE IT. THE SURGEON USED CLAMPS AND SUTURES TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 200545L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |