FDA Adverse Event
Malfunction
Summary report: N
NEW LIGASURE 5MM
MDR report key: 2132410
·
Received June 13, 2011
Report
- Report Number
- 1717344-2011-00453
- Event Type
- Malfunction
- Date Received
- June 13, 2011
- Date of Event
- May 12, 2011
- Report Date
- May 16, 2011
- 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
(B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVAL. IF THE SAMPLE IS REC'D, OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A GASTRECTOMY, OOZING OCCURRED ALTHOUGH AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE W/O INCIDENT. THERE WAS NO TISSUE DAMAGE AND NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEW LIGASURE 5MM | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 199940 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |