FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ATLAS HANDSWITCHING 20CM
MDR report key: 3101986
·
Received April 22, 2013
Report
- Report Number
- 3006451981-2013-00095
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Date of Event
- April 1, 2013
- Report Date
- April 3, 2013
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- 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 DURING A PANCREATECTOMY AND SPLENECTOMY PROCEDURE, THE DEVICE DID NOT SEAL PROPERLY. AN ENDTONE WAS HEARD, INDICATING A COMPLETED SEAL CYCLE, BUT BLEEDING WAS OBSERVED. THERE WAS NO INJURY TO THE PATIENT. ANOTHER LIGASURE WAS USED TO COMPLETE THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171772 | LIGASURE ATLAS HANDSWITCHING 20CM | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LLC (SHANGHAI) | S2M0006X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |