BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR, HIGH STRENGTH HOSE

    MDR report key: 3123930 · Received May 22, 2013

    Report

    Report Number
    1045834-2013-02161
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 22, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOTOR DEVICE WAS RECEIVED FOR EVALUATION. THE MOTOR DEVICE WAS TESTED AND IT A LEAK WAS OBSERVED NEAR THE PRESSURE RELEASE VALVE. EVIDENCE INDICATES THIS IS DUE TO USAGE WEAR OVER TIME. THE REPORTED CONDITION WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA REGARDING A MOTOR DEVICE IN WHICH A HOLE WAS OBSERVED IN THE "HOSE NEAR THE HANDPIECE" AND "IS LEAKING OIL". THE MOTOR DEVICE WAS NOT USED IN SURGERY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226095 XMAX MOTOR, HIGH STRENGTH HOSE DRILL, SURGICAL, ENT (PNEUMATIC)- HANDPIECE ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1