BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH FOR RESECTOSCOPE

    MDR report key: 5022453 · Received August 14, 2015

    Report

    Report Number
    9610617-2015-00066
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 14, 2015
    Report Date
    August 12, 2015
    Manufacturer
    KARL STORZ GMBH & TUTTLINGEN
    Product Code
    FBO
    PMA / PMN Number
    K943668
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT WAS EVALUATED. A PIECE OF THE CERAMIC BEAK IS BROKEN OFF AT DISTAL END OF INSTRUMENT. DAMAGE IS CONSISTENT WITH THE BEAK MAKING CONTACT WITH A HARD OBJECT OR STRESS OVERLOAD APPLIED. THE INSTRUMENT HAS A DATE CODE (B)(6); IT HAS BEEN IN USE FOR APPROXIMATELY 2 YEARS.

    Description of Event or Problem · 1

    ALLEGEDLY, DOCTOR WAS CONDUCTING A PROCEDURE (NAME UNKNOWN), WHEN CERAMIC BEAK ON INNER SHEATH OF RESECTOSCOPE BROKEN PIECE. PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540654 INNER SHEATH FOR RESECTOSCOPE INNER SHEATH WITH CERAMIC BEAK FBO KARL STORZ GMBH & TUTTLINGEN 27050CB UW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention