BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2988048 · Received February 19, 2013

    Report

    Report Number
    9613347-2013-00005
    Event Type
    Other
    Date Received
    February 19, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 18, 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 COIL FROM THE UNIT WAS SENT BACK AND FOUND TO BE FUNCTIONING. (B)(4)/DISTRIBUTOR PROVIDED TROUBLE SHOOTING INPUT TO (B)(4) (OWNER) AND IT WAS FOUND THAT PSQ/PCS, PULSE CURRENT SOURCE WAS NOT WORKING. THERE WAS A PART BROKEN IN THE HIGH VOLTAGE BOX WHICH CAUSED THE COIL NOT TO RECEIVE POWER. ALL MAINTENANCE HAS BEEN PERFORMED BY (B)(4) SINCE 2004. WE HAVE NO RECORD OF WHEN THE HIGH VOLTAGE COMPONENTS HAVE BEEN REPLACED, WHICH ARE TO BE REPLACED AT SCHEDULED INTERVALS. CAUSE MAY BE INADEQUATE MAINTENANCE.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A STONE FRAGMENTATION PROCEDURE, LITHOTRIPTER STOPPED FUNCTIONING; 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
    72600 KARL STORZ LITHOTRIPTOR- SLX LNS STORZ MEDICAL AG 3819 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other