BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROHYDRAULIC LITHOTRIPTER

    MDR report key: 40179 · Received September 30, 1996

    Report

    Report Number
    MW1010009
    Event Type
    Malfunction
    Date Received
    September 30, 1996
    Date of Event
    September 20, 1996
    Report Date
    September 30, 1996
    Manufacturer
    KARL STORZ ENDOSCOPY
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MFR CHANGED THE PACKAGING ON THE ELECTROHYDRAULIC LITHOTRIPTOR PROBES AND "STOPPED STERILIZING THEM." NOTHING ON THE NEW PACKAGING INDICATES THE PRODUCT MUST BE STERILIZED BEFORE USE. THE PACKAGING HAS THE TERM "GAMMA" AND "EXP" WHICH WOULD INDICATE DATE OF GAMMA IRRADIATION AND AN EXPIRATION DATE OF STERILE PRODUCT. THERE IS ALSO A CLAUSE WHICH STATES IF THE PRODUCT IS RESTERILIZED, THE INSTITUTION ASSUMES RESPONSIBILITY FOR EFFECTIVENESS. THE PACKAGING SHOULD STATE "UNSTERILE" IF THE PRODUCT HAS NOT BEEN STERILIZED. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROHYDRAULIC LITHOTRIPTER LITHOTRIPTER PROBE FFK KARL STORZ ENDOSCOPY 27080 GL 93/50/241

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other