BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPHTHALMIC DIATHERMY

    MDR report key: 19996 · Received February 27, 1995

    Report

    Report Number
    MW1005243
    Event Type
    Malfunction
    Date Received
    February 27, 1995
    Date of Event
    January 11, 1995
    Report Date
    February 1, 1995
    Manufacturer
    MIRA, INC.
    Product Code
    HQR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH STAB WOUND TO LEFT EYE, RUPTURED GLOBE AND LID LACERATION. ONE DAY AFTER THE SURGICAL REPAIR (OF SCLERAL CORNEAL, AND LID LACERATION) PT HAD HEMORRHAGE. A SECOND SURGERY DONE 10 DAYS LATER FOR VITRECTOMY/LENSECTOMY/DRAINAGE OF HEMMORRHAGE. DURING THIS SECOND SURGERY, THE DIATHERMY MACHINE WOULD NOT TURN OFF POWER TO THE DIATHERMY TIP WHEN THE SURGEON TOOK HIS FOOT OFF THE CONTROL PEDAL. AS A RESULT, THE TIP WOULD STICK TO THE PT'S SCLERA. BECAUSE THE EYE HAS SUSTAINED SUCH EXTENSIVE DAMAGE FROM THE ORIGINAL STAB INJURY, THERE WAS NO HOPE FOR SURVIVAL OF THE GLOBE OR USEFUL VISION, AND THE SURGERY WAS STOPPED. BIOMED CHECKED THE DIATHERMY UNIT AND FOUND DEFECTIVE FOOTPEDAL SOCKET. THE SOCKET WAS REPLACED AND THE DIATHERMY MACHINE WAS TESTED AND DETERMINED TO BE WORKING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPHTHALMIC DIATHERMY OPHTHALMIC DIATHERMY HQR MIRA, INC. TR3000

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other