BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHECKPOINT HEAD AND NECK

    MDR report key: 11985084 · Received June 11, 2021

    Report

    Report Number
    3012222873-2020-00001
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    July 24, 2020
    Report Date
    August 25, 2020
    Manufacturer
    CHECKPOINT SURGICAL INC.
    Product Code
    ETN
    PMA / PMN Number
    K150005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED DEVICE FAILED TO DETECT NERVE ACTIVITY RESULTING IN PATIENT INJURY, NERVE SEVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877449 CHECKPOINT HEAD AND NECK CHECKPOINT HEAD AND NECK ETN CHECKPOINT SURGICAL INC. 9394

    Patients

    Seq Age Sex Outcome Treatment
    1 Other