BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AL-II-FOOT CONTROL

    MDR report key: 3811298 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-13332
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    October 11, 2012
    Report Date
    October 17, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    GEI
    PMA / PMN Number
    K940535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA STATING THAT THE DEVICE'S CORD DISINTEGRATED AT THE BASE. IT IS KNOWN THAT THIS EVENT DID NOT OCCUR DURING SURGERY. IT WAS REPORTED THAT THERE WAS NO PT/USER INJURY RELATED TO THIS EVENT. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523930 AL-II-FOOT CONTROL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES - FOOT CONTROL GEI THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1