FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 1883893
·
Received October 22, 2010
Report
- Report Number
- 1717344-2010-00727
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- September 27, 2010
- Report Date
- October 5, 2010
- 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 EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AFTER A HYSTERECTOMY, THE SURGEON NOTICED 2ND DEGREE BURNS IN THE SURGICAL AREA. THE BURNS WERE TREATED WITH CREAM AND PLASTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 188437L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |