FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 2221486
·
Received August 17, 2011
Report
- Report Number
- 1717344-2011-00706
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- July 21, 2011
- Report Date
- July 28, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT DEVICE HAS BEEN REC'D AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETED A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORT THAT THE DEVICE FAILED TO ACTIVATE WHEN THE BUTTON WAS PUSHED. A NEW DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER DIFFICULTIES. THERE WAS NO PT INJURY. THE DEVICE WAS RETURNED WITH THE KNIFE BLADE EXPOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 205681LX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR |