FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT THORACIC
MDR report key: 2190096
·
Received June 30, 2011
Report
- Report Number
- 1717344-2011-00522
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- May 21, 2011
- Report Date
- June 8, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR 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 DURING A HYSTERECTOMY, THE DEVICE JAWS BECAME JAMMED ON TISSUE DURING THE FIRST USAGE. THE DEVICE WAS WIGGLED OFF WITH NO TISSUE DAMAGE IN ORDER TO REMOVE IT. THE KNIFE OF THE DEVICE WAS REPORTED AS BEING EXPOSED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF SUTURES. 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) | 205770LX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |