FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 2212092
·
Received July 8, 2011
Report
- Report Number
- 1717344-2011-00546
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- June 22, 2011
- Report Date
- July 6, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). TO DATE THE INCIDENT SAMPLE 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 TOTAL ABDOMINAL HYSTERECTOMY AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS PROVIDED BY THE GENERATOR, BUT THE DEVICE DID NOT COMPLETE THE SEALING PROCESS. THE SURGEON OPENED A SECOND DEVICE AND COMPLETED THE PROCEDURE WITH ON FURTHER DIFFICULTIES. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 203033LX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |