BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 8873493 · Received August 8, 2019

    Report

    Report Number
    9610773-2019-00107
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    June 27, 2019
    Report Date
    August 8, 2019
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761029339
    PMA / PMN Number
    K931994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THERE WAS NO LOT NUMBER PROVIDED THEREFORE, A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE LAST 24 MONTHS OF PRODUCTION WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUE. THE INSTRUCTION FOR USE (IFU) WARNS BEFORE USE MAKE SURE THAT THE PRODUCT HAS BEEN PROPERLY REPROCESSED, INSPECTED, AND TESTED. A DAMAGED SHEATH CAN CAUSE INJURY TO THE URETHRA. IF THE OBTURATOR¿S DISTAL END DOES NOT MOVE WHEN INSERTED INTO THE PATIENT, DO NOT TRY TO REMOVE THE OBTURATOR FROM THE SHEATH. REMOVE THE ENTIRE SHEATH/OBTURATOR ASSEMBLY FROM THE PATIENT. OTHERWISE, THE SHEATH¿S DISTAL END MAY BE DAMAGED. IF THE DEVICE IS RETURNED OR ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. OTHER 510K NUMBER = K931995

    Description of Event or Problem · 1

    THE MANUFACTURER WAS INFORMED THAT DURING A CYSTOSCOPY, URETEROPYELOGRAM, BLADDER BIOPSY WITH EVACUATION OF CLOTS, A PORTION OF THE INNER SHEATH TIP BROKE OFF INSIDE OF THE PATIENT. THE PIECE OF THE DEVICE WAS FULLY RETRIEVED BY THE PHYSICIAN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667623 INNER SHEATH, FOR 26 FR. OUTER SHEATH HYSTEROSCOPE HIH OLYMPUS WINTER & IBE GMBH A22040A NOT AVAILABLE 04042761029339

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR