BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROHYDRAULIC LITHOTRIPSY

    MDR report key: 51693 · Received September 27, 1996

    Report

    Report Number
    1418479-1996-00014
    Event Type
    Malfunction
    Date Received
    September 27, 1996
    Date of Event
    August 28, 1996
    Report Date
    September 3, 1996
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    FFK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ELECTROHYDRAULIC LITHOTRIPSY WAS BEING USED TO BREAK A STONE IN A PT'S URETER. THE GENERATOR DID NOT FIRE THE EHL PROBES. THE SURGEON DID NOT CONTINUE THE PROCEDURE, BUT PLACED A URINARY STENT IN THE URETER. NO ADDITIONAL SURGERY WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROHYDRAULIC LITHOTRIPSY ELECTROHYDRAULIC LITHOTRIPSY FFK RICHARD WOLF MEDICAL INSTRUMENTS 2280.004 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN