FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ATLAS HANDSWITCHING 37CM
MDR report key: 2222416
·
Received July 14, 2011
Report
- Report Number
- 1717344-2011-00564
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Date of Event
- June 13, 2011
- Report Date
- June 27, 2011
- Manufacturer
- COVIDIEN LP (US SURGICAL)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE HAS BEEN REQUESTED BY 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 AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD, BUT AFTER CUTTING THE TISSUE, BLEEDING OCCURRED. ANOTHER DEVICE WAS USED TO STOP THE BLEEDING AND COMPLETE THE PROCEDURE W/O INCIDENT. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE ATLAS HANDSWITCHING 37CM | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (US SURGICAL) | N9B28K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |