BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CCU, ARTHREX SYNERGY UHD4

    MDR report key: 18956124 · Received March 21, 2024

    Report

    Report Number
    1220246-2024-01624
    Event Type
    Injury
    Date Received
    March 21, 2024
    Date of Event
    November 16, 2020
    Report Date
    March 21, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GCJ
    UDI-DI
    00888867197022
    PMA / PMN Number
    K153218
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. (NO PROBLEM FOUND) THE EVALUATION DID NOT IDENTIFY ANY ISSUES RELEVANT TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CAMERA SHOCKED THE SURGEON WHEN HE TRIED TO FOCUS. ADDITIONAL INFORMATION OBTAINED 11/16/20: THE SALES REP REPORTED THAT THE SHOCK WAS LIKE A JOLT WHEN THE SURGEON WEN TO FOCUS. THE JOLT WAS FELT ON THE PALM OF HIS HAND. THE SURGEON FINISHED UP WITH THE CASE. THE SURGEON RECEIVED NO BURNS AND THE JOLT OCCURRED THROUGH HIS SURGICAL GLOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323938 CCU, ARTHREX SYNERGY UHD4 LAPAROSCOPE GCJ ARTHREX, INC. CCU, ARTHREX SYNERGY UHD4 UNK 00888867197022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other