BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARC ENDOCUFF

    MDR report key: 5279366 · Received December 9, 2015

    Report

    Report Number
    1651395-2015-00012
    Event Type
    Malfunction
    Date Received
    December 9, 2015
    Date of Event
    December 4, 2015
    Report Date
    December 9, 2015
    Manufacturer
    BODDINGTONS PLASTICS LTD
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THREE ENDOCUFF FINGERS DETACHED FROM THE ENDOCUFF BODY INSIDE THE PATIENT DURING AN ENDOSCOPIC PROCEDURE. THE FINGERS DESCENDED ON THEIR OWN AND THERE WAS NO HARM TO THE PATIENT. (B)(4) IS IN CONTACT WITH THE DEVICE MANUFACTURER. THIS COMPLAINT WILL CONTINUE TO BE MONITORED WITHIN THE MEDIVATORS COMPLAINT HANDLING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808069 ARC ENDOCUFF ENDOSCOPIC ACCESS OVERTUBE FED BODDINGTONS PLASTICS LTD AEC130

    Patients

    Seq Age Sex Outcome Treatment
    1