FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 1903054
·
Received November 12, 2010
Report
- Report Number
- 1717344-2010-00817
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 8, 2010
- Report Date
- October 28, 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 EVAL. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL 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 AND KNIFE BECAME DAMAGED DUE TO POSSIBLE CLOSURE OF CLAMPS THAT WERE IN USE IN THE PROCEDURE. THE DEVICE BECAME LOCKED ON TISSUE AND THE SURGEON REMOVED THE DEVICE BY CUTTING SURROUNDING TISSUE. THERE WAS NO PT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 177186L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |