FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ATLAS HANDSWITCHING 37CM
MDR report key: 3222152
·
Received July 2, 2013
Report
- Report Number
- 3006451981-2013-00214
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- May 30, 2013
- Report Date
- May 31, 2013
- Manufacturer
- COVIDIEN LLC
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 THE DEVICE STOPPED WORKING DURING THE SEAL CYCLE. AN ENDTONE (INDICATING A COMPLETED SEAL CYCLE) WAS HEARD, ALTHOUGH THE DEVICE HAD STOPPED WORKING AND THE SEAL WAS NOT YET COMPLETE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301764 | LIGASURE ATLAS HANDSWITCHING 37CM | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LLC | S0M0017P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |