BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS FLEXIBLE SURGICAL INSTRUMENTS

    MDR report key: 2052442 · Received March 15, 2011

    Report

    Report Number
    9610773-2011-00008
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    December 17, 2010
    Report Date
    February 14, 2011
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS CONTACTED THE USER FACILITY VIA PHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED PHENOMENON WAS UNABLE TO BE CONCLUSIVELY DETERMINED. IF RELEVANT AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER DATE, THEN THIS REPORT WILL BE SUPPLEMENTED. OLYMPUS AMERICA INC. IS FILING MDRS ON BEHALF OF GYRUS ACMI AND OLYMPUS MEDICAL SYSTEMS CORPORATION. GYRUS ACMI REGISTRATION NUMBERS 2183680 AND 1037007. (B)(4). THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH WHICH STATES, "DURING A CYSTO STENT EXCHANGE PROCEDURE, THE CYSTO GRASPER WAS PLACED INTO THE BLADDER AND A PIECE FELL OFF INTO THE BLADDER. THE DR WAS ABLE TO PULL THE PIECE OUT WITH ANOTHER GRASPER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS FLEXIBLE SURGICAL INSTRUMENTS FORCEPS KNW OLYMPUS WINTER & IBE GMBH O0122 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GRASPER: UNSPECIFIED MODEL AND SERIAL NUMBER| GRASPER: UNSPECIFIED MODEL AND SERIAL NUMBER