FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ADVANCE PISTOL GRIP
MDR report key: 3003710
·
Received February 11, 2013
Report
- Report Number
- 1717344-2013-00073
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Report Date
- January 15, 2013
- Manufacturer
- COVIDIEN LP
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COVIDIEN REFERENCE NUMBER: (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED 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 KNIFE BLADE WOULD NOT ADVANCE. THE SURGEON APPLIED FORCE TO THE TRIGGER TO ADVANCE THE KNIFE BLADE AND THIS CAUSED A PIECE OF BLUE JAW TO FALL OFF OF THE DEVICE INTO THE PT CAVITY. THE PIECE WAS RETRIEVED AND THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 60105 | LIGASURE ADVANCE PISTOL GRIP | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |