BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 16567331 · Received March 17, 2023

    Report

    Report Number
    9610773-2023-00801
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    February 19, 2023
    Report Date
    March 17, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO THE OLYMPUS FOR EVALUATION AND THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. THE CERAMIC INSULATION AT THE DISTAL TIP OF THE DEVICE WAS FOUND LOOSE AND THE BLACK CAP IS MISSING. THE INSPECTION ALSO NOTED, THE GUIDE SCREW IS MISSING, THE GUIDE PIN IS DAMAGED, AND THE SEALING RINGS WERE DAMAGED. THE DEVICE HAS NOT BEEN REPAIRED IN THE LAST YEAR. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE CAUSE CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE END-USER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. ADDITIONAL 501(K): K931995.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED, DURING INSPECTION PRIOR TO USE, THE CERAMIC INSULATION AT THE DISTAL TIP OF THE INNER SHEATH WAS FOUND BROKEN AND A SWITCH IS MISSING. THE SCHEDULED THERAPEUTIC UROLOGY PROCEDURE WAS COMPLETED USING A SIMILAR SHEATH WITHOUT DELAY. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER WAS REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548325 INNER SHEATH, FOR 26 FR. OUTER SHEATH INNER SHEATH HIH OLYMPUS WINTER & IBE GMBH A22040A 149W-0151 04042761029339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OLYMPUS MODEL: OTV-S7