BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STORZ

    MDR report key: 99594 · Received June 23, 1997

    Report

    Report Number
    99594
    Event Type
    Injury
    Date Received
    June 23, 1997
    Date of Event
    May 22, 1997
    Report Date
    June 9, 1997
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA INC.
    Product Code
    FGK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILED ATTEMPT TO BREAK UP BLADDER STONES WITH ELECTRO HYDRAULIC LITHOTRIPSY FOLLOWING MULTIPLE ATTEMPTS DUE TO INTERMITTENT FIRING PROBLEM. A STORZ LITHOTRITE JAWS BROKE APART REQUIRING SURGICAL OPENING OF THE BLADDER TO REMOVE THE STONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ LITHOTRITE FGK KARL STORZ ENDOSCOPY-AMERICA INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention ELECTROHYDRAULIC LITHOTRIPTER CIRCON CORPORATION