FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 3810209
·
Received February 4, 2014
Report
- Report Number
- 1717344-2014-00060
- Event Type
- Malfunction
- Date Received
- February 4, 2014
- Date of Event
- January 13, 2014
- Report Date
- January 13, 2014
- Manufacturer
- COVIDIEN LP
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A GASTRECTOMY, THE BLADE OF THE DEVICE BECAME STUCK WHILE IN USE, AND WAS PROTRUDING FROM THE JAWS OF THE DEVICE. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73652 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP | 237069LX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |