FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ATLAS HANDSWITCHING 37MM
MDR report key: 3150089
·
Received April 16, 2013
Report
- Report Number
- 3006451981-2013-00103
- Event Type
- Malfunction
- Date Received
- April 16, 2013
- Date of Event
- February 5, 2013
- Report Date
- March 26, 2013
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 ADDITIONAL INFORMATION 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 SUPRACERVICAL HYSTERECTOMY, AFTER COMPLETING A SEAL CYCLE WITH THE DEVICE, THE SURGEON OPENED THE JAWS OF THE INSTRUMENT AND THE SEAL PLATE INSERT BECAME DISLODGED. THERE WAS NO HARM TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 163249 | LIGASURE ATLAS HANDSWITCHING 37MM | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LLC (SHANGHAI) | S2H0015X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |