FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ADVANCE PISTOL GRIP
MDR report key: 2190104
·
Received June 30, 2011
Report
- Report Number
- 1717344-2011-00527
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- June 9, 2011
- Report Date
- June 10, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- UNKNOWN
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 REPORTED THAT THE SILICONE INSULATION SLEEVE CAME OFF THE DEVICE WHILE WORKING INSIDE THE PT. THE PIECE WAS RETRIEVED. THERE WAS NO PT INJURY.
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 |