BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ROTATABLE CLIP FIXING DEVICE

    MDR report key: 4003135 · Received June 26, 2014

    Report

    Report Number
    8010047-2014-00364
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 18, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT PRODUCT WAS RETURNED TO OMSC FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THAT THE PART WHICH HELD ON THE CLIP WAS DEFORMED AND THE CLIP DETACHED FROM IT. TUBE JOINT TORE FROM THE TUBE SHEATH. IN ADDITION, THERE WAS HANDLE DAMAGE AND COIL SHEATH BENT NEAR HANDLE. THE SLIDER WORKED SMOOTHLY. ALSO, AS THE RESULT OF CHECKING THE MFG RECORD OF THE SAME LOT, NOTHING ABNORMAL DETECTED. OMSC THEREFORE ASSUMES THAT THIS EVENT WAS ATTRIBUTED TO THE LARGE ANGLE OF THE BENDING SECTION OF THE ENDOSCOPE OR THE HANDLE MISHANDLING. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MED SYSTEMS CORP (OMSC) WAS INFORMED THAT THE CLIP COULD NOT BE DETACHED FROM THE DEVICE AFTER CLIPPING TISSUE. THE DOCTOR TRIED TO PULL OUT THE TUBE SHEATH SEVERAL TIMES BUT THE CLIP COULD NOT BE DISLODGED FROM THE TISSUE. THE NURSE TOOK PLIERS TO PREVENT THE TISSUE FROM TEARING AND ATTEMPTED TO CUT THE INSERTION PORTION OF THE DEVICE. WHEN THE NURSE LIFTED THE HANDLE, THE CLIP BROKE AWAY FROM THE DEVICE. THE DOCTOR REPLACED THE SUBJECT DEVICE WITH ANOTHER AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY REGARDING THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372930 SINGLE USE ROTATABLE CLIP FIXING DEVICE CLIP FIXING DEVICE FZG OLYMPUS MEDICAL SYSTEMS CORPORATION HX-201UR-135L K3604

    Patients

    Seq Age Sex Outcome Treatment
    1