BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND SWITCH FOR ELECTRIC PEN DRIVE

    MDR report key: 2970807 · Received February 20, 2013

    Report

    Report Number
    8030965-2013-00577
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE RETURNED TO SYNTHES (B)(4) - DATE UNKNOWN. DEVICE WAS EVALUATED BY SYNTHES (B)(4): RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM COULD NOT BE CONFIRMED OR DUPLICATED; THE UNIT WAS TESTED AND PASSED ALL OPERATIONAL SPECIFICATIONS, AND NO PROBLEMS WERE NOTED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAND SWITCH FOR AN ELECTRIC PEN DRIVE RUNS IN LOCKED POSITION. THIS IS 1 OF 1 REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74977 HAND SWITCH FOR ELECTRIC PEN DRIVE SWITCH FZX SYNTHES GMBH AV16078

    Patients

    Seq Age Sex Outcome Treatment
    1