FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ATLAS HANDSWITCHING 37CM
MDR report key: 1983226
·
Received February 2, 2011
Report
- Report Number
- 3006451981-2010-00106
- Event Type
- Malfunction
- Date Received
- February 2, 2011
- Date of Event
- November 24, 2010
- Report Date
- January 11, 2011
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DATE OF INITIAL REPORT: (B)(4) 2011. THE INCIDENT DEVICE HAS BEEN REC'D AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHEN THE DEVICE WAS USED IN A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, THE GRAY INSULATION WAS TORN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NOTHING FELL INTO THE PT CAVITY, NO TISSUE DAMAGED AND THERE WAS NO PT INJURY. UPON RETURN AND INITIAL VISUAL INSPECTION, THE INCIDENT DEVICE WAS FOUND TO HAVE BARE JAW WIRES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE ATLAS HANDSWITCHING 37CM | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LLC (SHANGHAI) | S0F0031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |