BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2997607 · Received February 19, 2013

    Report

    Report Number
    9613347-2013-00004
    Event Type
    Other
    Date Received
    February 19, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 15, 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 FAILURE OF THE UNIT WAS DUE TO THE COIL. THE COIL WAS SENT TO SMAG FOR EVALUATION; THE MANUFACTURER STATES THAT THE PROBABLE CAUSE OF COIL FAILURE WAS INADEQUATE MAINTENANCE DUE TO THE FACT THAT THE UNIT HAS NOT BEEN SERVICED BY KARL STORZ SINCE 2004 AND IT CANNOT BE CONFIRMED THAT IT WAS SERVICED TO CORRECT SPECIFICATIONS BY THE OWNER.

    Description of Event or Problem · 1

    MOR IS BASED ON PRELIMINARY INFORMATION RECEIVED BY KARL STORZ, WHO HAS NOT CONCLUSIVELY DETERMINED THE CAUSE OF THE ADVERSE EVENT. THIS MOR IS, THEREFORE, NOT INTENDED TO AND SHALL NOT CONSTITUTE AN ADMISSION THAT A REPORTABLE EVENT OCCURRED OR THAT ANY KARL STORZ PRODUCTS WERE CAUSALLY RELATED TO THE INCIDENT. ALLEGEDLY, DURING A STONE FRAGMENTATION PROCEDURE, LITHOTRIPTOR FAILED; PROCEDURE WAS ABORTED AND RESCHEDULED. NO IMPACT ON PATIENT. THIS OCCURRED AT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72232 KARL STORZ LITHOTRIPTOR - SLX LNS STORZ MEDICAL AG 3819 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other