BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH, FOR 26 FR. OUTER SHEATH

    MDR report key: 4897835 · Received July 8, 2015

    Report

    Report Number
    9610773-2015-00029
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    June 26, 2015
    Report Date
    June 26, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS 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 DEVICE IS RETURNED FOR EVALUATION/INVESTIGATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED. OLYMPUS SUBMITS THIS INCIDENT AS A MEDICAL DEVICE REPORT (MDR) IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A DIAGNOSTIC TRANSPERINEAL BIOPSY OF THE PROSTATE (TPB) PROCEDURE, THE CERAMIC INSULATION AT THE DISTAL END OF THE SUSPECT MEDICAL DEVICE DETACHED AND FELL INSIDE THE PATIENT'S URETHRA. THIS OCCURRED WHEN THE OPERATING SURGEON WITHDREW THE INNER SHEATH FROM THE PATIENT. HOWEVER, NO FRAGMENT/PART REMAINED INSIDE THE PATIENT AS THE CERAMIC INSULATION WAS REPORTEDLY RETRIEVED BY UNKNOWN APPROACH. THE INTENDED PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH THE SAME MEDICAL DEVICE AND THERE WAS NO ADVERSE EVENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442235 INNER SHEATH, FOR 26 FR. OUTER SHEATH RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS FJL OLYMPUS WINTER & IBE GMBH 07XW

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED URETHROSCOPE