FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT THORACIC
MDR report key: 2070767
·
Received April 14, 2011
Report
- Report Number
- 1717344-2011-00294
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- February 1, 2011
- Report Date
- March 17, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DATE OF INITIAL REPORT: (B)(4) 2011. THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN REC'D FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS REC'D OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE LOCKED SHUT ON A LARGE, FIBROUS PEDICLE AND THE BLADE WAS DAMAGED. TO DATE, THE CUSTOMER HAS NOT RESPONDED TO ADDITIONAL QUESTIONS REGARDING THE INCIDENT. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE IMPACT THORACIC | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 190871L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |