FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ADVANCE PISTOL GRIP
MDR report key: 3983529
·
Received June 26, 2014
Report
- Report Number
- 1717344-2014-00553
- Event Type
- Malfunction
- Date Received
- June 26, 2014
- Date of Event
- June 4, 2014
- Report Date
- June 12, 2014
- Manufacturer
- COVIDIEN LP
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATIONS IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE CLEAR INSULATION WAS SLIDING OUT OF PLACE DURING A HYSTERECTOMY AND APPENDECTOMY. A SECOND HANDPIECE OF THE SAME TYPE WAS OPENED AND USED SUCCESSFULLY TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 373878 | LIGASURE ADVANCE PISTOL GRIP | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP | 224599X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |