FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ATLAS HANDSWITCHING 37CM
MDR report key: 3941445
·
Received April 16, 2014
Report
- Report Number
- 3006451981-2014-00597
- Event Type
- Malfunction
- Date Received
- April 16, 2014
- Date of Event
- March 25, 2014
- Report Date
- March 27, 2014
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A LAPAROSCOPIC SALPINGO CASE, THE DEVICE JAWS COULD NOT BE REOPENED WHILE APPLIED TO TISSUE. THE SURGEON REMOVED THE DEVICE FROM THE TISSUE BY USING ANOTHER DEVICE TO RESECT THE TISSUE DIRECTLY ADJACENT TO THE LOCKED JAWS. THERE WAS NO INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232162 | LIGASURE ATLAS HANDSWITCHING 37CM | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LLC (SHANGHAI) | S3K0006X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |