FDA Adverse Event
Malfunction
Summary report: N
LIGASURE BLUNT TIP LAP SEALER/DIVIDER
MDR report key: 3983530
·
Received June 26, 2014
Report
- Report Number
- 1717344-2014-00555
- Event Type
- Malfunction
- Date Received
- June 26, 2014
- Date of Event
- June 11, 2014
- Report Date
- June 13, 2014
- Manufacturer
- COVIDIEN LP
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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 BLEEDING OF LESS THAN 100ML WAS OBSERVED DURING A SLEEVE GASTRECTOMY ALTHOUGH END TONES, INDICATING A COMPLETED SEAL CYCLE, WERE HEARD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT AND THERE WAS NO INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 373967 | LIGASURE BLUNT TIP LAP SEALER/DIVIDER | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP | 40310127X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |