FDA Adverse Event
Malfunction
Summary report: N
LIGASURE HS MAX DISP ELECT/CORD
MDR report key: 2241591
·
Received September 2, 2011
Report
- Report Number
- 1717344-2011-00791
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- March 26, 2011
- Report Date
- June 30, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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 INITIALLY REPORTED THAT DURING USE, THE DEVICE STOPPED WORKING. A SMALL GRAY PIECE FELL OFF THE JAWS. THERE WERE NO CONSEQUENCES FOR THE PT. THE DEVICE WAS RETURNED AND A VISUAL INSPECTION REVEALED A BARE WIRE ON THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE HS MAX DISP ELECT/CORD | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 200547 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |