FDA Adverse Event
Malfunction
Summary report: N
LIGASURE V SEALER/DIVIDER
MDR report key: 1082436
·
Received July 21, 2008
Report
- Report Number
- 1717344-2008-00334
- Event Type
- Malfunction
- Date Received
- July 21, 2008
- Date of Event
- June 24, 2008
- Report Date
- June 25, 2008
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 REPORT STATED THAT AFTER ACTIVATION, OOZING BLEEDING OCCURRED WHILE SEALING THE OMENTUM MAJUS. THE GENERATOR WAS SET AT 2 BARS AND GAVE AN END TONE INDICATING A COMPLETED SEAL. NO TISSUE DAMAGED. ANOTHER DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE V SEALER/DIVIDER | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 137504 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | FORCETRIAD ENERGY PLATFORM - SERIAL NUMBER UNK |