BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SINGLE USE LEGATING DEVICE

    MDR report key: 3101951 · Received April 22, 2013

    Report

    Report Number
    8010047-2013-00131
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 24, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORT WITH NO RESULT. THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME DUE TO THE ABSENCE OF THE DEVICE TO INVESTIGATE. IF THE DEVICE IS RECEIVED LATER AND ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A COLONOSCOPY WITH POLYPECTOMY, WHILE THE USER REPORTEDLY WAS REMOVING THE SUBJECT DEVICE FROM THE POLYP, THE TRANSPARENT PLASTIC SHEATH BECAME LODGED IN THE POLYP AND THE METALLIC PART DETACHED. THE POLYP WAS BLEEDING. THE SUBJECT DEVICE WAS CUT AT THE PROXIMAL PART, AND THE ENDOSCOPE WAS REMOVED. THE USER REPORTEDLY UTILIZED A SNARE TO REMOVE THE SUBJECT DEVICE FROM THE POLYP. THEN CLIPS WERE USED TO STOP THE BLEEDING OF THE POLYP. PATIENT WENT INTO THE OBSERVATION ROOM AND WAS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171691 OLYMPUS SINGLE USE LEGATING DEVICE POLY LOOP GEI OLYMPUS MEDICAL SYSTEMS CORPORATION HX-400U-30 24K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention OLYMPUS ENDOSCOPE, MODEL / SERIAL NUMBER UNKNOWN| CLIP, MODEL / LOT # UNKNOWN| SNARE, MODEL / LOT # UNKNOWN