BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVO SURGICAL MCIVOR MOUTH GAG

    MDR report key: 8480591 · Received April 3, 2019

    Report

    Report Number
    3008770252-2019-00001
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    February 7, 2019
    Report Date
    April 3, 2019
    Manufacturer
    NOVO SURGICAL INC.
    Product Code
    KBN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NOVO SURGICAL STARTED ITS PRELIMINARY INVESTIGATION BY OBTAINING ADDITIONAL INFORMATION FROM THE USER/FACILITY AND REQUESTING THAT THE AFFECTED PRODUCTS BE RETURNED. THE RETURNED PRODUCTS WERE EVALUATED BY NOVO SURGICAL'S QUALITY ASSURANCE FOR THEIR TENSILE STRENGTH TO DETERMINE IF THE PRODUCTS MET SPECIFICATION. ONCE THE FRAMES WERE SECURED PROPERLY TO THE HANDLES, THE EVALUATED DEVICES WERE ABLE TO WITHSTAND FORCE IN SIGNIFICANT EXCESS OF WHAT WOULD TYPICALLY BE ENCOUNTERED IN SURGERY. NO NON-CONFORMITIES WERE OBSERVED WITH THESE DEVICES. NOVO SURGICAL IDENTIFIED NO CORRECTIVE ACTIONS. IT IS POSSIBLE THAT THE FRAME WAS NOT AFFIXED SECURELY TO THE HANDLE AT THE TIME IT CAME APART AND/OR THAT THE USE OF AN ADULT FRAME ON A PEDIATRIC PATIENT CONTRIBUTED TO THE INJURY AS SIGNIFICANTLY MORE PRESSURE WOULD NEED TO BE APPLIED TO FIT AN ADULT GAG INTO THE MOUTH OF A PEDIATRIC PATIENT. A DEVICE HISTORY REVIEW UNCOVERED NO PREVIOUS RECORDED QUALITY PROBLEMS OR COMPLAINTS ASSOCIATED WITH THIS ITEM.

    Description of Event or Problem · 1

    NOVO SURGICAL INC. RECEIVED A SUS VOLUNTARY EVENT REPORT FROM THE FDA (REPORT MW5084100) NOTIFYING IT OF A MDR SUBMITTED BY A USER/FACILITY WITH REGARDS TO A MCIVOR MOUTH GAG (ITEM NO. 4553-20) SUPPLIED BY NOVO SURGICAL. THE FDA CORRESPONDENCE DATED FEBRUARY 27, 2019 WAS DELIVERED VIA POSTAL MAIL AND RECEIVED BY NOVO SURGICAL ON MARCH 6, 2019. THIS WAS THE FIRST NOTIFICATION TO NOVO SURGICAL OF THIS COMPLAINT. THIS PRODUCT IS COMPRISED OF TWO PARTS (A FRAME AND HANDLE) THAT ARE TO BE ASSEMBLED TOGETHER WITH TWO DETACHABLE SCREWS WHEN IN USE. THE PRODUCT MAY BE DISASSEMBLED DURING STERILIZATION. IN THE SUS VOLUNTARY EVENT REPORT, THE USER/FACILITY HAD INDICATED THAT THE ITEM CAME APART AS IT WAS BEING POSITIONED IN A PEDIATRIC PATIENT'S MOUTH AND KNOCKED OUT ONE OF THE PATIENT'S FRONT TOP INCISORS AND SIGNIFICANTLY LOOSENED ANOTHER. USER/FACILITY ALSO REPORTED THAT ONE OF THE SCREWS OF THE MOUTH GAGS WAS FOUND TO BE MISSING AND NOT RECOVERED AND THAT X-RAY CONFIRMED THAT THE PATIENT DID NOT SWALLOW THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273559 NOVO SURGICAL MCIVOR MOUTH GAG MCIVOR MOUTH GAG KBN NOVO SURGICAL INC. 4553-20 M4/17

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR