FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ATLAS HANDSWITCHING 20CM
MDR report key: 3983220
·
Received June 27, 2014
Report
- Report Number
- 1717344-2014-00492
- Event Type
- Malfunction
- Date Received
- June 27, 2014
- Date of Event
- May 1, 2014
- Report Date
- June 4, 2014
- Manufacturer
- COVIDIEN LLP (SHANGHAI)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
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 INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A PROCEDURE TO REMOVE THE HEAD OF THE PANCREAS, THE JAWS OF THE DEVICE WOULD NOT REOPEN WHILE APPLIED TO TISSUE. IT IS UNK HOW THE DEVICE WAS REMOVED FROM THE PT TISSUE. THERE WAS NO TISSUE DAMAGE OR UNANTICIPATED BLEEDING, AND NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 378409 | LIGASURE ATLAS HANDSWITCHING 20CM | LIGASURE VESSEL SEALING SYS | GEI | COVIDIEN LLP (SHANGHAI) | S3M002X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |