FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT THORACIC
MDR report key: 2910630
·
Received December 4, 2012
Report
- Report Number
- 1717344-2012-01193
- Event Type
- Malfunction
- Date Received
- December 4, 2012
- Date of Event
- October 12, 2012
- Report Date
- November 28, 2012
- Manufacturer
- COVIDIEN LP
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER ORIGINALLY REPORTED THAT THE DEVICE ALARMED AND DID NOT FUNCTION PROPERLY. THERE WAS NO ACTIVATION FROM THE DEVICE. ANOTHER DEVICE WAS OPENED IN ORDER TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE DEVICE WAS RETURNED FOR EVALUATION WITH THE KNIFE BLADE EXPOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE IMPACT THORACIC | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP | 218708LX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |