BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE LIGATING DEVICE

    MDR report key: 8369012 · Received February 26, 2019

    Report

    Report Number
    2951238-2019-00461
    Event Type
    Malfunction
    Date Received
    February 26, 2019
    Date of Event
    January 28, 2019
    Report Date
    March 18, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FHN
    UDI-DI
    04953170368615
    PMA / PMN Number
    K980465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM FDT TO FHN.

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE ESTABLISHED DUE TO THE ABSENCE OF THE DEVICE TO EVALUATE; HOWEVER, THE MOST LIKELY CAUSE OF THIS TYPE OF DEVICE ISSUE ARE AS FOLLOWS: THE TUBE SHEATH MAY NOT BE RETRACTED FULLY, THE POLYP WAS TOO LARGE, AND THE LOOP MAY NOT HAVE BEEN SET PROPERLY.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC COLONOSCOPY PROCEDURE, WHEN THE USER PLACED THE LOOP AROUND A POLYP, THE WIRE HOLDING THE LOOP BROKE IN HALF AND THE USER WAS NOT UNABLE TO RELEASE THE LOOP AS DESIGNED. THEY HAD TO USE THE LOOP CUTTER TO CUT THE LOOP FREE (WHICH WORKED FINE). NO PATIENT INJURY REPORTED. THE INTENDED PROCEDURE WAS COMPLETED. DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165824 SINGLE USE LIGATING DEVICE SINGLE USE LIGATING DEVICE FHN OLYMPUS MEDICAL SYSTEMS CORP. HX-400U-30 84V 04953170368615

    Patients

    Seq Age Sex Outcome Treatment
    1