FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 2041535
·
Received March 10, 2011
Report
- Report Number
- 1717344-2011-00153
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- January 31, 2011
- Report Date
- February 16, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DATE OF INITIAL REPORT: 03/10/2011. 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 AFTER PERFORMING A GYN PROCEDURE, IT WAS NOTICED THAT THE PT HAD A BURN THE VULVIC AREA. THE SURGEON STATED THE BURN WAS SECOND DEGREE, WAS APPROX 2 CM. IN DIAMETER AND TREATED THE BURN WITH SILVADENE CREAM. THE SITE HAS INDICATED THAT THE INCIDENT DEVICE HAS BEEN DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |