FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ATLAS HANDSWITCHING 37CM
MDR report key: 2121461
·
Received May 6, 2011
Report
- Report Number
- 3006451981-2011-00074
- Event Type
- Malfunction
- Date Received
- May 6, 2011
- Date of Event
- April 26, 2011
- Report Date
- May 2, 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 INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED 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 LADG PROCEDURE WITH THE FORCETRIAD SET AT 2 BARS, OOZING OCCURRED FROM THE GREATER OMENTUM EVEN THOUGH AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD. THIS OOZING OCCURRED AGAIN WHEN THE GENERATOR WAS INCREASED TO 3 BARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE ATLAS HANDSWITCHING 37CM | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LLC (SHANGHAI) | S1A0006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | FORCETRIAD - ENERGY PLATFORM - S/N UNK |