FDA Adverse Event
Malfunction
Summary report: N
LIGASURE V SEALER/DIVIDER
MDR report key: 3701994
·
Received February 18, 2014
Report
- Report Number
- 3006451981-2014-00325
- Event Type
- Malfunction
- Date Received
- February 18, 2014
- Date of Event
- July 11, 2011
- Report Date
- August 30, 2011
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SITE INDICATED THA THE INCIDENT SAMPLE WAS DISCARDED. 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 TOWARD THE END OF A LAPAROSCOPIC-ASSISTED HYSTERECTOMY, THE DEVICE JAWS COULD NOT BE RE-OPENED WHILE ON TISSUE. THE DEVICE JEWS WERE REMOVED FROM THE TISSUE BY RESECTING THE TISSUE ADJACENT TO THE JAWS. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102461 | LIGASURE V SEALER/DIVIDER | LIGASURE VESSEL SEALING SYS | GEI | COVIDIEN LLC (SHANGHAI) | SOGB009B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |