BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2990108 · Received February 22, 2013

    Report

    Report Number
    9613347-2013-00007
    Event Type
    Other
    Date Received
    February 22, 2013
    Date of Event
    January 4, 2013
    Report Date
    February 22, 2013
    Manufacturer
    STORZ MEDICAL AG
    Product Code
    LNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LITHOTRIPTOR STOPPED WORKING DUE TO FAILURE OF COIL. THE COIL WAS SENT TO THE MFR FOR EVAL. THEY FOUND THAT THE COIL WAS ASSEMBLED CORRECTLY, WITH ALL PARTS MOUNTED; IT WAS DRY AND THE OUTER INSULATION OF THE MEMBRANE TO WATER WAS GOOD. THEY COULD NOT DETERMINE A REASON FOR FAILURE.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A STONE FRAGMENTATION PROCEDURE, LITHOTRIPTOR FAILED; PROCEDURE WAS ABORTED AND RESCHEDULED. NO IMPACT ON PT. THIS OCCURRED AT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78430 KARL STORZ LITHOTIPTOR - SLX LNS STORZ MEDICAL AG 3819 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other