BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPULSE SELECT HO:YAG LASER

    MDR report key: 46090 · Received September 16, 1996

    Report

    Report Number
    2914019-1996-00008
    Event Type
    Malfunction
    Date Received
    September 16, 1996
    Date of Event
    August 8, 1996
    Report Date
    September 10, 1996
    Manufacturer
    COHERENT MEDICAL GROUP
    Product Code
    LNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINICAL STUDY. DURING A LASER RESECTION OF THE PROSTATE, THE LASER LOST POWER, RESULTING IN THE PROCEDURE BEING PROLONGED AND EVENTUALLY TERMINATED PRIOR TO COMPLETION. PT THEN HAD A DISTENDED, PAINFUL ABDOMEN WHICH REQUIRED ADMINISTRATION OF MORPHINE AND DITROPAN FOR DISCOMFORT -- ALSO IV FLUIDS WERE ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPULSE SELECT HO:YAG LASER SURGICAL LASER LNK COHERENT MEDICAL GROUP VERSAPULSE SELECT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other