FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 2063328
·
Received April 1, 2011
Report
- Report Number
- 1717344-2011-00243
- Event Type
- Malfunction
- Date Received
- April 1, 2011
- Date of Event
- February 27, 2011
- Report Date
- March 29, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 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 MEDWATCH STATED: THE SURGEON WAS USING A LIGASURE HAND PIECE FOR SEALING TISSUE FOR SEVERAL MINUTES AND IT SEEMED TO BE WORKING FINE. AFTER SEALING SOME TISSUE, THE HAND PIECE WOULD NOT OPEN AND WAS STUCK ONTO THE TISSUE. SURGEON HAD TO USE A SURGICAL BLADE TO CUT TISSUE TO REMOVE BLADE FROM THE TISSUE. THE CUSTOMER STATED THERE WAS NO PT INJURY. PROCEDURE BEING PERFORMED IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 198718L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |