BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH WITH CERAMIC BEAK

    MDR report key: 9311529 · Received November 12, 2019

    Report

    Report Number
    9610617-2019-00104
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    March 6, 2019
    Report Date
    November 7, 2019
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    HIH
    UDI-DI
    04048551078136
    PMA / PMN Number
    K882270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE CERAMIC TIP WAS SENT IN FOR INVESTIGATION. ACCORDING TO THE MANUFACTURE UPON EXAMINATION THEY FOUND THAT THE BROKEN SURFACE IS PARTIAL DISCOLORED. DAMAGES LIKE THIS HAPPEN IF THE CERAMIC INSERT IS HIT AGAINST HARD OBJECTS OR EDGES. THE DAMAGE OF THE PRODUCT IS NOT CAUSED BY A PRODUCTION PROBLEM OR MATERIAL DEFECT. THE CERAMIC TIP IS LIGHT GREY-WHITE, AND SUGGEST THAT IT IS AN OLD MODEL. SINCE (B)(6) 2005 DARK GREY ONES WERE USED.

    Description of Event or Problem · 1

    AS PER A VIGILANCE REPORT FILED BY THE FACTORY IN GERMANY, ALLEGEDLY, DURING A UROLOGY PROCEDURE IN GB, A PIECE OF THE CERAMIC TIP BROKE INSIDE THE PATIENT AND WAS UNDETECTED AT THE TIME. THE PATIENT RETURNED 3 MONTHS LATER, THE BEAK WAS FOUND AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107072 INNER SHEATH WITH CERAMIC BEAK INNER TUBE WITH CERAMIC BEAK HIH KARL STORZ SE & CO. KG 27050XA 04048551078136

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention