FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 2980966
·
Received February 4, 2013
Report
- Report Number
- 3006451981-2013-00027
- Event Type
- Malfunction
- Date Received
- February 4, 2013
- Date of Event
- January 31, 2013
- Report Date
- February 1, 2013
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). TO DATE THE INCIDENT SAMPLE 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 PELVIC EXENTERATION, THE KNIFE OF THE DEVICE WAS DESCRIBED AS PROTRUDING FROM BEYOND THE JAWS. THE SURGEON OPENED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45977 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LLC (SHANGHAI) | S2JS044X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |