BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 4976065 · Received August 6, 2015

    Report

    Report Number
    9610773-2015-00038
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    July 30, 2015
    Report Date
    July 30, 2015
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FJL
    PMA / PMN Number
    K931995
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICES WERE NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION. THEREFORE THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IF THE SUSPECT MEDICAL DEVICES ARE RETURNED FOR EVALUATION/INVESTIGATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED. OLYMPUS SUBMITS THIS EVENT/INCIDENT AS A MEDICAL DEVICE REPORT (MDR) IN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS RETURNED TO THE MANUFACTURER TO BE EVALUATED/INVESTIGATED. THE EVALUATION/INVESTIGATION CONFIRMED THAT THE CERAMIC INSULATION AT THE DISTAL END OF THE INNER SHEATH A22040A HAD BROKEN OFF AND FRACTURED. FURTHERMORE, THE SHEATH TUBE IS DEFORMED. THE CAUSE OF THIS DAMAGE AND THE SUBSEQUENT BREAKAGE OF THE CERAMIC INSULATION IS MECHANICAL OVERLOAD BY THE INAPPROPRIATE ATTEMPT TO REMOVE THE DAMAGED AND DEFECTIVE GRASPING FORCEPS A20710A. THEREFORE THIS EVENT/INCIDENT WAS ATTRIBUTED TO ABNORMAL USE/OFF-LABEL USE. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE, BUT THE REPORTED PHENOMENON WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES. FURTHERMORE, THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS AND PRO RE NATA RETRAINED TO CORRECTLY USE THE OLYMPUS MEDICAL DEVICES.

    Description of Event or Problem · 1

    CROSS-REFERENCE TO MFR REPORT # 9610773-2015-00037. THIS IS REPORT 2 OUT OF 2. OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED TRANSURETHRAL LITHOTRIPSY PROCEDURE, THE GRASPING FORCEPS A20710A BROKE INSIDE THE PATIENT WHILE ATTEMPTING TO CRUSH A BLADDER STONE. AT THE SAME TIME, THE CERAMIC INSULATION AT THE DISTAL END OF THE INNER SHEATH A22040A BROKE OFF AND FELL INSIDE THE PATIENT'S BLADDER. THE FRAGMENTS WERE REPORTEDLY RETRIEVED BY UNKNOWN APPROACH BUT THE OPERATING SURGEON WAS UNCERTAIN WHETHER ALL PIECES OF THE CERAMIC INSULATION WERE REMOVED FROM THE PATIENT'S BLADDER. THE INTENDED PROCEDURE WAS SUBSEQUENTLY COMPLETED AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520787 INNER SHEATH, FOR 26 FR. OUTER SHEATH RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS FJL OLYMPUS WINTER & IBE GMBH 142W

    Patients

    Seq Age Sex Outcome Treatment
    1