BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM INTERCONNECT HIGH FREQUENCY UNIPOLAR CABLES

    MDR report key: 8965020 · Received September 4, 2019

    Report

    Report Number
    MW5089559
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 9, 2019
    Report Date
    September 1, 2019
    Manufacturer
    NURSE ASSIST LLC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HIGH FREQUENCY UNIPOLAR CABLE ("MONOPOLAR CORD") HAD A PIECE OF PLASTIC IN THE CONNECTOR AND THE SURGEON WAS UNABLE TO CONNECT THE INSTRUMENT TO THE CORD. THIS OCCURRED PRIOR TO SURGERY START, IT WAS REMOVED FROM THE STERILE FIELD PRIOR TO SURGERY START AND IT WAS NOT USED ON THE PT. DEFECT IDENTIFIED WHILE PLUGGING IN INSTRUMENT. NEVER USED ON PT. THE SURGERY LEADERSHIP UPON REVIEW REVEALED THE DEFECT WAS NOTED TO BE READILY APPARENT UPON PLUGGING IN THE INSTRUMENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757034 QUANTUM INTERCONNECT HIGH FREQUENCY UNIPOLAR CABLES ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI NURSE ASSIST LLC. 1901055

    Patients

    Seq Age Sex Outcome Treatment
    1