BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHECKPOINT HEAD & NECK

    MDR report key: 11920251 · Received June 2, 2021

    Report

    Report Number
    3012222873-2021-00001
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    May 19, 2021
    Report Date
    May 26, 2021
    Manufacturer
    CHECKPOINT SURGICAL INC.
    Product Code
    ETN
    PMA / PMN Number
    K150005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING HOSPITAL PROTOCOL, THE DR. REMOVED HIS GLOVE, RINSED HIS FINGER IN ALCOHOL, RE-SCRUBBED AND RE- GLOVED. ALSO, PER HOSPITAL PROTOCOL, A BLOOD SAMPLE WAS TAKEN FROM THE PATIENT, A REPORT COMPLETED AND, FOLLOWING THE CASE, THE SURGEON WAS SEEN IN THE ER. LOCAL REP CONFIRMED THAT THE DEVICE WAS THROWN AWAY. ALTHOUGH THE DEVICE DID NOT MALFUNCTION AND THERE WAS NO SERIOUS INJURY IN THIS INSTANCE, THIS USE ERROR COULD POTENTIALLY CONTRIBUTE TO A SERIOUS INJURY IF IT WERE TO RECUR AND THE PATIENT HAD A BLOOD BORNE PATHOGEN.

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE DEVICE, THEN RETURNING IT TO THE NURSE BETWEEN USES. AFTER USING A FEW TIMES, THE SURGEON WAS GIVEN THE DEVICE BY THE NURSE AND WAS HOLDING THE DEVICE AND THE ANODE. HE ATTEMPTED STIMULATION, THEN WAS REMINDED TO PLACE THE ANODE. WHEN HE WENT TO PLACE THE ANODE, HE ACCIDENTALLY POKED HIS FINGER WITH THE NEEDLE. FOLLOWING HOSPITAL PROTOCOL, HE REMOVED HIS GLOVE, RINSED HIS FINGER IN ALCOHOL, RE-SCRUBBED AND RE- GLOVED. ALSO, PER HOSPITAL PROTOCOL, A BLOOD SAMPLE WAS TAKEN FROM THE PATIENT, A REPORT COMPLETED AND, FOLLOWING THE CASE, THE SURGEON WAS SEEN IN THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817040 CHECKPOINT HEAD & NECK CHECKPOINT HEAD & NECK ETN CHECKPOINT SURGICAL INC. 9394

    Patients

    Seq Age Sex Outcome Treatment
    1 Other