BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ

    MDR report key: 4232358 · Received October 23, 2014

    Report

    Report Number
    1221826-2014-00051
    Event Type
    Malfunction
    Date Received
    October 23, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 25, 2014
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FBO
    PMA / PMN Number
    K062918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCOPE WAS EVALUATED AND WE FOUND THAT IT HAS BEEN REPAIRED BY A THIRD PARTY. IT HAS NON-KARL STORZ MATERIALS ON THE SHAFT, MASK, AND ADHESIVE. THERE ARE DEEP SCRAPE MARKS THAT PUNCTURED WORKING CHANNEL AND CAUSED LEAKING. THE FIELD LENS TO BUNDLE SEPARATION IS DUE TO CORROSION, AND CORRODED HOUSING ASSEMBLY CAUSED THE LOSS OF DEFLECTION. IT'S MISSING THERMO INSULATION SLEEVE WAS RETRIEVED FROM PATIENT, BUT IT WAS NOT RETURNED WITH THE SCOPE. THE BIOMED LATER CONFIRMED IT WAS DISCARDED. WE SUSPECT THAT MISSING SLEEVE HAS BEEN REPAIRED BY A THIRD PARTY AND IS NO LONGER KARL STORZ MATERIAL.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A TURP PROCEDURE, IT WAS REPORTED THAT THE THERMO INSULATION SLEEVE CAME OUT OF DISTAL END OF THE SCOPE AND WAS RETRIEVED FROM THE PATIENT'S KIDNEY. THE HOSPITAL USED A COMPETITOR'S RESECTOSCOPE TO COMPLETE THE PROCEDURE. PATIENT IS DOING FINE POSTOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674436 KARL STORZ FLEXIBLE URETEROSCOPE FBO KARL STORZ ENDOVISION 11278AU1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention