BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC COVIDIEN GROUNDING PAD

    MDR report key: 19163921 · Received April 22, 2024

    Report

    Report Number
    MW5154096
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    February 5, 2024
    Report Date
    April 18, 2024
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE REPORTED EVENT WAS THAT AFTER A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE WHEN THE GROUND PAD WAS REMOVED FROM THE PATIENT, A WOUND WAS SEEN. THE GROUNDING PAD WAS PLACED ON THE PATIENT'S SHOULDER, AND THE PATIENT WAS POSITIONED IN A STEEP TRENDELENBURG POSITION. THE LENGTH OF THE PROCEDURE WAS APPROXIMATELY 10 HOURS. THE PATIENT WILL BE FOLLOWED BY A WOUND CARE TEAM. THE SURGEON STATED THAT THERE WAS NO FAILURE WITH THE DA VINCI. THE OR DIRECTOR REPORTED THAT THE GROUNDING PAD THAT WAS USED DURING THE PROCEDURE WAS A MEDTRONIC COVIDIEN GROUNDING PAD. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070369 MEDTRONIC COVIDIEN GROUNDING PAD ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown