BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCULAN 3TI DERMATOME

    MDR report key: 6247326 · Received January 12, 2017

    Report

    Report Number
    9610612-2017-00020
    Event Type
    Malfunction
    Date Received
    January 12, 2017
    Report Date
    April 11, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    GFD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: USA. IT IS REPORTED THAT THE DERMATOME IS NOT TAKING AN EFFECTIVE SKIN GRAFT.

    Additional Manufacturer Narrative · 1

    THE GA670 WAS DELIVERED ON 27.05.15, A REPAIR OR MAINTENANCE IS NOT REGISTERED IN SAP. VISUALLY, THE DERMATOME IS IN A USED CONDITION, THE DEVICE IS ADDITIONALLY LABELED WITH A "STRANGER" MAINTENANCE DATE (09/2017). THE ORIGINAL MAINTENANCE STAMP IS MISSING, AND SHOULD BE 09/2016. FURTHERMORE, A FLAP AND THE KNURLED NUT OF THE FLAP ROD ARE MISSING. FUNCTIONALLY, THE GA670 IS OKAY EXCEPT THE MISSING PARTS. THE MOTOR FUNCTION AND RUNNING NOISE ARE OK, THE CUTTING SAMPLE WAS ALSO OK. ONLY THE TWO CLAMPING LEVERS ARE SET "BAD". THE TRANSACTION IS STORED IN THE ATS WITH THE EXCEPTION OF FURTHER CONFIRMATION OF QMV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30826 ACCULAN 3TI DERMATOME POWER SYSTEMS ORTHOPAEDICS GFD AESCULAP AG GA670 52132322

    Patients

    Seq Age Sex Outcome Treatment
    1 Other