FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ADVANCE PISTOL GRIP
MDR report key: 3221419
·
Received June 28, 2013
Report
- Report Number
- 1717344-2013-00476
- Event Type
- Malfunction
- Date Received
- June 28, 2013
- Date of Event
- May 31, 2013
- Report Date
- June 11, 2013
- Manufacturer
- COVIDIEN LP
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE JAWS WOULD NOT GRASP TISSUE AND THE KNIFE BLADE WOULD NOT ADVANCE. THERE WAS NO INJURY TO THE PT. THE DEVICE WAS RETURNED TO COVIDIEN FOR INVESTIGATION AND VISUAL INSPECTION DISCOVERED THAT BOTH WEBBINGS WERE PROTRUDING FROM THE HINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295293 | LIGASURE ADVANCE PISTOL GRIP | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP | 250376X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |