FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT THORACIC
MDR report key: 2121435
·
Received May 5, 2011
Report
- Report Number
- 1717344-2011-00287
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Date of Event
- April 7, 2011
- Report Date
- April 8, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SITE INDICATED THAT THE INCIDENT SAMPLE WAS DISCARDED. IF ADD'L INFO 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 JAWS BECAME JAMMED DURING USE AND THE KNIFE WAS PROTRUDING. THE DEVICE WAS DISCARDED BY THE SITE AFTER THE PROCEDURE. A COVIDIEN REP HAS HAD A CONSULTATION WITH THE SURGEON AND NO ADD'L DETAILS ABOUT THE INCIDENT COULD BE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE IMPACT THORACIC | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 196900L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |