FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ATLAS HANDSWITCHING 37CM
MDR report key: 2220040
·
Received August 12, 2011
Report
- Report Number
- 3006451981-2011-00079
- Event Type
- Malfunction
- Date Received
- August 12, 2011
- Date of Event
- May 16, 2011
- Report Date
- May 20, 2011
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER INITIALLY REPORTED THAT AFTER OPENING THE PACKAGE, IT WAS NOTED THAT ONE PIECE OF THE WIRE INSULATION HAD FALLEN OFF. THE INCIDENT DEVICE WAS RETURNED AND A VISUAL INSPECTION REVEALED THAT THE JAW WIRE WAS BARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE ATLAS HANDSWITCHING 37CM | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LLC (SHANGHAI) | SOG0043P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |