FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ATLAS HANDSWITCHING 20CM
MDR report key: 2241570
·
Received September 2, 2011
Report
- Report Number
- 3006451981-2011-00124
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- August 17, 2011
- Report Date
- August 21, 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 RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT 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 300CC OF BLEEDING OCCURRED ALTHOUGH AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE, THERE WAS NO TISSUE DAMAGE AND NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE ATLAS HANDSWITCHING 20CM | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LLC (SHANGHAI) | S1B0004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |