FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ATLAS HANDSWITCHING 37CM
MDR report key: 2190097
·
Received June 30, 2011
Report
- Report Number
- 1717344-2011-00524
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 6, 2011
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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 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 THE DEVICE PROVIDED INCONSISTENT SEALING AND ACTIVATION. NO FURTHER INFO ON THE INCIDENT WAS MADE AVAILABLE BY THE SITE. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE ATLAS HANDSWITCHING 37CM | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LLC (SHANGHAI) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |