FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 2221485
·
Received August 17, 2011
Report
- Report Number
- 1717344-2011-00711
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- August 2, 2011
- Report Date
- August 2, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVAL. IF THE SAMPLE IS REC'D 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 CUSTOMER REPORTED THAT DURING AN OPEN COLECTOMY, THE DEVICE JAWS WERE UNABLE TO BE RE-OPENED. THE JAWS WERE CUT OFF TISSUE IN ORDER TO REMOVE THEM. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER DIFFICULTIES. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |