FDA Adverse Event
Malfunction
Summary report: N
LIGASURE V SEALER/DIVIDER
MDR report key: 2200820
·
Received March 31, 2011
Report
- Report Number
- 3006451981-2011-00049
- Event Type
- Malfunction
- Date Received
- March 31, 2011
- Date of Event
- March 4, 2011
- Report Date
- March 7, 2011
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AFTER THE THIRD SEAL CYCLE OF A COLECTOMY, OOZING OCCURRED EVEN THOUGH AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD. 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) | S0MB003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |