FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ADVANCE PISTOL GRIP
MDR report key: 2241587
·
Received September 2, 2011
Report
- Report Number
- 1717344-2011-00784
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- April 20, 2011
- Report Date
- August 18, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, THE DEVICE WOULD NO LONGER OPEN WHILE ON UTERINE TISSUE. THE DEVICE WAS EXCISED FROM TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO PATIENT 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) | 203775X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |