FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ADVANCE PISTOL GRIP
MDR report key: 2023779
·
Received February 15, 2011
Report
- Report Number
- 1717344-2011-00105
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- January 20, 2011
- Report Date
- January 21, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT DEVICE HAS BEEN REC'D AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A WHIPPLE PROCEDURE, THE DEVICE STOPPED WORKING. THE SURGEON NOTICED A LACK OF STEAM AND SMOKE WHICH ALERTED HIM TO THE FACT THAT THE DEVICE WAS NOT SEALING. IT IS UNK WHETHER OR NOT AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD WHEN THE DEVICE DID NOT SEAL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. 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) | 198230 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |