FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 2041539
·
Received March 10, 2011
Report
- Report Number
- 1717344-2011-00175
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- January 5, 2011
- Report Date
- March 1, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT DEVICE HAS BEEN REC'D AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE LOCKED UP WHILE THE SURGEON WAS CUTTING. THE DEVICE WAS REMOVED WITH NO TISSUE DAMAGE. THE DEVICE WAS RETURNED FOR EVAL WITH THE KNIFE PROTRUDING FROM BEYOND THE JAWS.
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 |