BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1525554 · Received November 4, 2009

    Report

    Report Number
    9610617-2009-00037
    Event Type
    Other
    Date Received
    November 4, 2009
    Date of Event
    September 30, 2009
    Report Date
    November 2, 2009
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL REPORTED THERE WAS NO MALFUNCTION OF THE INSTRUMENT. THE 27076A MECHANICAL LITHOTRITE WAS EVALUATED AT THE FACILITY BY OUR FIELD SERVICE TECHNICIAN, WHO FOUND IT WAS FUNCTIONING PROPERLY. EACH 27076A MECHANICAL LITHOTRITE SHIPS WITH AN INSTRUCTION TAG ATTACHED TO THE LITHOTRITE. THE TAG EXPLAINS HOW TO SAFELY REMOVE THE INSTRUMENT SHOULD THE JAWS BECOME MISALIGNED; HOSPITAL CONFIRMED THE TAG WAS ON THE INSTRUMENT.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A CYSTOSCOPY PROCEDURE TO REMOVE BLADDER STONES, THE 27074B STONE CRUSHING FORCEPS BROKE AND THE DOCTOR SWITCHED TO A MECHANICAL LITHOTRITE, MODEL 27076A, TO BREAK UP THE STONES. THE JAWS OF THE MECHANICAL LITHOTRITE BECAME MISALIGNED AND THE DOCTOR COULD NOT BE REMOVE IT FROM THE PT. DOCTOR SWITCHED TO A CYSTOSTOMY TO REMOVE THE LITHOTRITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ MECHANICAL LITHOTRITE FFK KARL STORZ GMBH & CO. KG 27076A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other