FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 2140604
·
Received June 16, 2011
Report
- Report Number
- 1717344-2011-00498
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- June 13, 2011
- Report Date
- June 15, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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 SAME 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 THE DEVICE JAWS BECAME LOCKED WHILE CUTTING TISSUE. THE DEVICE WAS CUT OFF IN ORDER TO REMOVE IT FROM TISSUE. THERE WAS NO PATIENT INJURY. THE SITE CONTACT WAS NOT ABLE TO PROVIDE ADDITIONAL DETAILS REGARDING THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |