BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 16382198 · Received February 15, 2023

    Report

    Report Number
    9610773-2023-00509
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    January 17, 2023
    Report Date
    February 15, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761029339
    PMA / PMN Number
    K931994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PMA/510(K) NUMBER K931995. THE DEVICE WAS RETURNED TO OLYMPUS. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE CUSTOMER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT DURING MAINTENANCE BY CUSTOMER, IT WAS FOUND THAT THE CERAMIC TIP PARTS BROKE OFF. THERE WAS NO INJURY OR HEALTH DAMAGE DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317766 INNER SHEATH, FOR 26 FR. OUTER SHEATH HYSTEROSCOPE HIH OLYMPUS WINTER & IBE GMBH A22040A 111W-0016 04042761029339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown