BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE ROTATABLE CLIP FIXING DEVICE

    MDR report key: 2112671 · Received April 29, 2011

    Report

    Report Number
    8010047-2011-00087
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 31, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    MND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THE REPORT, BUT DID NOT RECEIVE DETAILED INFO REGARDING THE REPORTED EVENT. THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL AND FOUND THAT THE CLIP AND CLIP BRACKET WERE ABSENT. THERE WAS EVIDENCE OF BIOMATERIAL NOTED ON THE DEVICE, WHICH LIMITED THE EVAL TO VISUAL INSPECTION ONLY. THE DEVICE WILL BE FORWARDED TO THE ORIGINAL EQUIPMENT MANUFACTURER FOR FURTHER INVESTIGATION. IF ADDITIONAL AND SIGNIFICANT INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC ESOPHOGOGASTRODUODENOSCOPY (EGD) PROCEDURE, A CLIP FIXATION DEVICE WAS DEPLOYED, HOWEVER AN ADDITIONAL PIECE OF METAL REPORTEDLY STAYED ATTACHED TO THE CLIP, AND REPORTEDLY REMAINED INSIDE THE PT'S BODY CAVITY. THERE WAS NO REPORT OF PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE USE ROTATABLE CLIP FIXING DEVICE CLIP FIXING DEVICE MND OLYMPUS MEDICAL SYSTEM CORPORATION HX-201UR-135L K0Z090

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED SERIAL NUMBER| OLYMPUS HX-201UR-135L CLIP WITH LOT# K0Z090| OLYMPUS GIF-160 SCOPE WITH