BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX III MO3

    MDR report key: 384047 · Received March 18, 2002

    Report

    Report Number
    1625507-2002-00030
    Event Type
    Malfunction
    Date Received
    March 18, 2002
    Report Date
    February 12, 2002
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    "LEAKED OIL DURING A CASE" WAS REPORTED TO MMR TECHNICAL SUPPORT. ON FOLLOW UP IT WAS REPORTED THAT THE SURGEON NOTICED OIL ON HIS GLOVES. THEY EXAMINED THE MOTOR AND FOUND OIL SEEPING OUT AT THE CONNECTION FROM THE MOTOR TO THE HOSE. THEY WRAPPED THE CONNECTION WITH TAPE AND COMPLETED THE CASE WITHOUT INCIDENT. NO INTERVENTION WAS REQUIRED, ALTHOUGH ADDITIONAL IRRIGATION WAS USED IMMEDIATELY AFTER THE OIL WAS DETECTED. THE MOTOR WAS WORKING FINE OTHERWISE. NO PATIENT INJURY OR UNUSUAL DELAY IN SURGERY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDAS REX III MO3 PNEUMATIC SURGICAL DRILL, MIDAS HBB MEDTRONIC MIDAS REX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO