FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ATLAS HANDSWITCHING 37CM
MDR report key: 2212090
·
Received July 8, 2011
Report
- Report Number
- 1717344-2011-00542
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 14, 2011
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DATE OF INITIAL REPORT: (B)(6) 2011. THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVAL. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. 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 AFTER SEALING, THE DEVICE JAWS COULD NO LONGER OPEN. THE JAWS WERE ABLE TO BE OPENED TO REMOVE THE DEVICE, BUT THE REMOVAL OF THE DEVICE CAUSED BLEEDING.
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 |