BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAC, CUSTOM ACS UNIVERSAL SET-UP JRSU11G

    MDR report key: 17167954 · Received June 20, 2023

    Report

    Report Number
    3011389083-2023-00001
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    May 24, 2023
    Report Date
    June 20, 2023
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    LRO
    UDI-DI
    00191072140548
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT IS NOT AVAILABLE FOR EVALUATION. AMERICAN CONTRACT SYSTEMS IS THE MANUFACTURER OF THE UNIVERSAL SETUP PACK JRSU11G. THE COMPLAINT COMPONENT MEDTRONIC CAUTERY PENCIL, PART NUMBER E2516NHSB IS MANUFACTURED BY COVIDIEN (FDA REGISTRATION 1717344). THE BOVIE PEN IS SUPPOSED TO BE HOLSTERED ONCE IT IS POWERED ON, AS IT CREATES HEAT. THE BOVIE PEN WAS NOT HOLSTERED WHILE NOT IN USE. WE HAVE DETERMINED THE INJURY OCCURRED DUE TO USER ERROR AT THE HOSPITAL. BECAUSE OF THIS DETERMINATION, A SCAR WAS NOT ISSUED TO THE SUPPLIER OF THE BOVIE PEN. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE ACS COMPLAINT DATABASE AS 23-075 AND ADVERSE EVENT ASSESSMENT IS IDENTIFIED AS RECORD CH-DT-2023-A1-20. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    A BOVIE PENCIL FROM UNIVERSAL SET-UP PACK ACTIVATED ON ITS OWN WHEN THE PLUG WAS INSERTED INTO THE ROBOT. THE PATIENT WAS ALREADY PREPPED AND DRAPED FOR THE PROCEDURE, NO ONE WAS UTILIZING THE BOVIE PENCIL AT THAT TIME. THE STAFF HEARD A BUZZING SOUND AND IMMEDIATELY REALIZED IT WAS THE BOVIE PENCIL. THE NURSE PULLED THE PLUG, AND THE SCRUB TECH THREW DEVICE OFF THE STERILE FIELD. UNFORTUNATELY, THE PATIENT WAS ALREADY BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692368 PAC, CUSTOM ACS UNIVERSAL SET-UP JRSU11G PAC, CUSTOM ACS UNIVERSAL SET-UP JRSU11G LRO AMERICAN CONTRACT SYSTEMS JRSU11G 893231 00191072140548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other