FDA Adverse Event
Malfunction
Summary report: N
LIGASURE V SEALER/DIVIDER
MDR report key: 2050395
·
Received April 4, 2011
Report
- Report Number
- 3006451981-2011-00052
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 7, 2011
- Report Date
- March 9, 2011
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DATE OF INITIAL REPORT: (B)(4) 2011. 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 A PORTION OF INSULATION CAME OFF THE SHAFT OF THE DEVICE WHILE THE INSTRUMENT WAS IN THE PATIENT. THE PIECE WAS RECOVERED AND THE INSTRUMENT WAS REMOVED FROM THE FIELD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE V SEALER/DIVIDER | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LLC (SHANGHAI) | S0MB004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |