BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER TUBE WITH CERAMIC BEAK

    MDR report key: 3973124 · Received June 5, 2014

    Report

    Report Number
    9610617-2014-00026
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    GCJ
    PMA / PMN Number
    K940347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS IN USE FOR 7 YEARS AND WAS REPAIRED AT SOME POINT BY A THIRD PARTY REPAIR GROUP (IMS). KARL STORZ DOES NOT AUTHORIZE OUTSIDE REPAIR OR PROVIDE REPLACEMENT PARTS.

    Description of Event or Problem · 1

    ALLEGEDLY,THE DOCTOR WAS AT THE END OF A PHOTOSELECTIVE ENUCLEATION PROCEDURE WHEN THE CERAMIC BEAK BROKE OFF THE DISTAL END OF THE DEVICE INTO THE PT. THE DOCTOR RETRIEVED IT AND WENT ON TO COMPLETE PROCEDURE. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328618 INNER TUBE WITH CERAMIC BEAK INNER TUBE GCJ KARL STORZ GMBH & CO. KG 27040XA AC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention