BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS QUICK CLIP2

    MDR report key: 1894092 · Received November 5, 2010

    Report

    Report Number
    8010047-2010-00223
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 8, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    MND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFO REGARDING THE REPORT, BUT NO RESULT. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFO PROVIDED BY THE USER FACILITY. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH REPORTED, WHICH STATED "THE CLIP DID NOT DEPLOY FROM THE SHEATH. IT IS UNK HOW THE EVENT OCCURRED. THE DEVICE DID NOT WORK. THE ORIGINAL INTENDED PROCEDURE WAS AN UPPER ENDOSCOPY PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS QUICK CLIP2 CLIP FIXING DEVICE MND OLYMPUS MEDICAL SYSTEM CORPORATION HX-201UR-135 0K6110

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR