FDA Adverse Event
Malfunction
Summary report: N
NEW LIGASURE 5MM
MDR report key: 2041558
·
Received March 10, 2011
Report
- Report Number
- 1717344-2011-00186
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- February 15, 2011
- Report Date
- February 17, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DATE OF INITIAL REPORT: (B)(4) 2011. THE SAMPLE HAS BEEN REQUESTED, BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVAL. IF THE SAMPLE IS REC'D 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 THE DEVICE WAS WORKING FINE BUT THEN STOPPED SEALING COMPLETELY. IT IS UNK IF REGRASP ALARMS OR END TONES WERE HEARD WHEN SEALING ISSUES OCCURRED. THE SURGEON OPENED ANOTHER DEVICE AND FINISHED THE PROCEDURE WITH NO FURTHER DIFFICULTIES. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEW LIGASURE 5MM | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 198229 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |