BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PMI

    MDR report key: 7369517 · Received March 26, 2018

    Report

    Report Number
    7369517
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Date of Event
    January 29, 2018
    Report Date
    March 12, 2018
    Manufacturer
    PROGRESSIVE MEDICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE LAPAROSCOPIC ELECTRODE POLYTETRAFLUOROETHYLENE (PTFE) COATED L-HOOK WAS BEING USED AND BEGAN TO SPARK WHILE INSIDE THE PATIENT. THE USE OF INSTRUMENT WAS STOPPED, REMOVED IMMEDIATELY, AND TAKEN OFF THE SURGICAL FIELD. THE ELECTROSURGICAL SETTINGS WERE 40/40. MATERIALS MANAGEMENT WAS NOTIFIED AND CAME TO OPERATING ROOM PROMPTLY TO GATHER INFORMATION FROM SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213691 PMI ELECTROSURGICAL,CUTTING, COAGULATION GEI PROGRESSIVE MEDICAL, INC. P0020 1707020

    Patients

    Seq Age Sex Outcome Treatment
    1