BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ ENDOSCOPY

    MDR report key: 72928 · Received February 25, 1997

    Report

    Report Number
    72928
    Event Type
    Malfunction
    Date Received
    February 25, 1997
    Date of Event
    February 20, 1997
    Report Date
    February 22, 1997
    Manufacturer
    STORZ ENDOSCOPY
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE TIP OF THE LITHOTRIPTOR PROBE FELL OFF INTO THE PT'S BLADDER AND WAS RETRIEVED AT THE END OF THE CASE. THE TIP OF THE SECOND PROBE APPEARED ABNORMALLY DISTORTED BY THE END OF THE PROCEDURE; ALL PROBES WITH THE SAME LOT NUMBER WERE PULLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ ENDOSCOPY ELECTROHYDRAULIC LITHOTRIPTOR PROBE FFK STORZ ENDOSCOPY NA 3096

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other