BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 4987941 · Received August 10, 2015

    Report

    Report Number
    9610773-2015-00040
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    July 29, 2015
    Report Date
    July 29, 2015
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FJL
    PMA / PMN Number
    K931995
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC), (B)(4)(RETURNED TO OMSC ON 2015-07-31). THE EVALUATION/INVESTIGATION CONFIRMED THE REPORTED PHENOMENON OF A BROKEN/FRACTURED CERAMIC INSULATION AT THE DISTAL END OF THE INNER SHEATH. A LARGE CERAMIC FRAGMENT IS BROKEN OFF. HOWEVER, NO PARTS ARE ACTUALLY MISSING. CAUSAL FOR THIS DAMAGE AND BREAKAGE OF THE CERAMIC INSULATION IS MECHANICAL OVERLOAD BY THE APPLICATION OF EXCESSIVE FORCE LIKE IMPACT, FALL, SHOCK OR SIMILAR STRESS. IT IS CLEARLY STATED AS A WARNING NOTE IN THE INSTRUCTIONS THAT IMPACT, FALL, SHOCK OR SIMILAR STRESS CAN DAMAGE THE CERAMIC INSULATION AT THE SHEATH'S DISTAL END AND THAT THE INSTRUMENT MUST NOT BE USED IF DAMAGED AS OTHERWISE THIS CAN CAUSE INJURIES TO THE PATIENT AND/OR USER. THE USER APPARENTLY DID NOT FOLLOW THESE INSTRUCTIONS AS THE DAMAGE AND BREAKAGE OF THE CERAMIC INSULATION WERE CAUSED BY MECHANICAL OVERLOAD. THEREFORE THIS EVENT/INCIDENT WAS ATTRIBUTED TO ABNORMAL USE/OFF-LABEL USE AND THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS. HOWEVER, THE EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES AND THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS AND PRO RE NATA TRAINED AGAIN ON THE CORRECT USAGE OF THE OLYMPUS MEDICAL DEVICES. OLYMPUS SUBMITS THIS EVENT/INCIDENT AS A MEDICAL DEVICE REPORT (MDR) IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE BLADDER TUMOR (TURBT) PROCEDURE, THE SURGICAL TEAM NOTICED THAT THE CERAMIC INSULATION AT THE DISTAL END OF THE INNER SHEATH HAD BROKEN/FRACTURED. IT IS UNKNOWN WHEN EXACTLY THIS DAMAGE OCCURRED AND WHETHER A FRAGMENT/PART FELL INSIDE THE PATIENT. HOWEVER, IT WAS CONFIRMED THAT NO FRAGMENTS/PARTS REMAINED INSIDE THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BUT THE INTENDED PROCEDURE WAS REPORTEDLY COMPLETED WITH THE SAME INNER SHEATH AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY. IN ADDITION, IT WAS REPORTED THAT THE INNER SHEATH HAD BEEN INSPECTED BEFORE THE PROCEDURE AND THAT NO ABNORMALITIES OR IRREGULARITIES WERE DETECTED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522184 INNER SHEATH, FOR 26 FR. OUTER SHEATH RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS FJL OLYMPUS WINTER & IBE GMBH 10XW

    Patients

    Seq Age Sex Outcome Treatment
    1