FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 2231307
·
Received July 25, 2011
Report
- Report Number
- 1717344-2011-00611
- Event Type
- Malfunction
- Date Received
- July 25, 2011
- Date of Event
- June 20, 2011
- Report Date
- July 20, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A TOTAL ABDOMINAL HYSTERECTOMY, THE DEVICE JAWS COULD NOT BE RE-OPENED. THE SURGEON OPENED ANOTHER DEVICE AND COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE DEVICE WAS RETURNED WITH THE KNIFE BLADE EXPOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 208064LX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |