BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLUBE-III

    MDR report key: 3182246 · Received June 21, 2013

    Report

    Report Number
    1045834-2013-02572
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    February 22, 2011
    Manufacturer
    DUPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DUPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA, STATING THAT THE DEVICE HAD HOSE DAMAGE. IT IS KNOWN THAT THIS EVENT DID NOT OCCUR DURING SURGERY. HOWEVER, IT IS UNKNOWN IF THERE WAS USER OR PATIENT INJURY OR MEDICAL INTERVENTION. THE DATE OF THE EVENT IS UNKNOWN. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281714 AUTOLUBE-III MOTOR, SURGICAL INSTRUMENT, AC-POWERED - FOOT CONTROL GEY DUPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1