BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX I MO

    MDR report key: 381358 · Received March 6, 2002

    Report

    Report Number
    1625507-2002-00025
    Event Type
    Malfunction
    Date Received
    March 6, 2002
    Report Date
    February 4, 2002
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    "LEAKING OIL" IS NOTED ON CUSTOMER REPAIR PAPERWORK. ON FOLLOW UP, IT WAS REPORTED THAT DURING SURGERY, THE DR NOTICED OIL RESIDUE ON THE THUMB OF HIS GLOVED HAND. THE UNIT WAS TAKEN OUT AND ANOTHER UNIT WAS BROUGHT IN TO COMPLETE THE CASE. NO OIL DRIPPED INTO THE PT WOUND SITE. THERE WERE NO INJURIES AND NO UNUSUAL DELAYS AS A RESULT. THE HOSP CONTACT REPORTED THAT A THIRD PARTY HAD REPAIRED THEIR MOTORS FOR QUITE SOME TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO