BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGI-TIP TRANSDUCER COVER

    MDR report key: 5784837 · Received July 12, 2016

    Report

    Report Number
    5784837
    Event Type
    Malfunction
    Date Received
    July 12, 2016
    Date of Event
    June 20, 2016
    Report Date
    June 21, 2016
    Manufacturer
    CIVCO MEDICAL INSTRUMENTS CO., INC.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A CHILD WAS UNDERGOING A LAMINOPLASTY. AFTER INITIAL FIRST INCISION, A SURGI-TIP TRANSDUCER COVER #610-833 (LOT NUMBER M941840) WAS USED IN THE STERILE PROCEDURE TO COVER THE ULTRASOUND PROBE. THE PROBE WAS PLACED INTO THE STERILE COVER. ONCE THE ULTRASOUND PROBE WITH COVER WAS PLACED ON THE STERILE FIELD, THE RUBBER PART OF THE COVER BROKE AND THE PROBE WAS DISCOVERED TO BE UNSTERILE WHICH WAS NOW IN THE SURGICAL SITE. DR. DECIDED TO STOP THE PROCEDURE, A CULTURE OF THE WOUND WAS COMPLETED, AND VANCOMYCIN POWDER PLACED ON THE INCISION. THE INCISION WAS CLOSED. DR HAD NOT ENTERED THE DURA AT THE TIME THE PROBE WAS DISCOVERED TO BE UNSTERILE. PATIENT DISCHARGED WITH ANTIBIOTICS AND WILL RETURN FOR IN 3-4 WEEKS FOR LAMINOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438920 SURGI-TIP TRANSDUCER COVER TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX CIVCO MEDICAL INSTRUMENTS CO., INC. 610-833 M941840

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR