BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECKPOINT

    MDR report key: 7112068 · Received December 13, 2017

    Report

    Report Number
    7112068
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 24, 2017
    Report Date
    November 29, 2017
    Manufacturer
    CHECKPOINT SURGICAL INC
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO USING THE EQUIPMENT IN A HEAD/NECK SURGERY, SURGEON WAS UNCAPPING THE CHECKPOINT WHEN THE NEEDLE DETACHED FROM THE WIRE CONNECTION, NO HARM TO THE PATIENT. DEVICE WAS REMOVED FROM THE SURGICAL FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894433 CHECKPOINT STIMULATOR, NERVE ETN CHECKPOINT SURGICAL INC 9094 7016

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR