FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ADVANCE PISTOL GRIP
MDR report key: 2212088
·
Received July 8, 2011
Report
- Report Number
- 1717344-2011-00539
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- May 15, 2011
- Report Date
- June 16, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, 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 F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER INITIALLY REPORTED THAT THE DEVICE KNIFE BLADE LOCKED DURING USE. THERE WAS NO PT INJURY. THE INCIDENT DEVICE WAS RETURNED AND A VISUAL INSPECTION REVEALED THAT THE KNIFE WAS PROTRUDING FROM THE JAWS OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE ADVANCE PISTOL GRIP | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |