BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ ENDOSCOPY - AMERICAN INC.

    MDR report key: 2565374 · Received April 25, 2012

    Report

    Report Number
    MW5025306
    Event Type
    Injury
    Date Received
    April 25, 2012
    Date of Event
    April 5, 2012
    Report Date
    April 12, 2012
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CYSTOSCOPY AND LITHOLAPAXY OF BLADDER CALCULI, THE INSTRUMENT BROKE AT THE POINT WHERE THE JAWS CLOSE. A TINY PIECE WAS IN THE BLADDER THAT WAS RETRIEVED. PATIENT WILL RETURN TO REMOVE THE REST OF THE STONES AT ANOTHER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ ENDOSCOPY - AMERICAN INC. STORZ STONE CRUSHER FFL KARL STORZ ENDOSCOPY-AMERICA PRODUCT # 27074B OY 2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention