BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACGYVER MOUTH RETRACTOR/MCIVOR

    MDR report key: 8343540 · Received February 14, 2019

    Report

    Report Number
    MW5084100
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    February 7, 2019
    Report Date
    February 12, 2019
    Manufacturer
    NOVA SURGICAL, INC.
    Product Code
    EIF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MACGYVER MOUTH RETRACTOR FROM NOVO SURGICAL USED FOR T&A PROCEDURE WAS PLACED IN THE MOUTH OF (B)(6) PATIENT. WHEN RETRACTOR WAS BEING POSITIONED IT CAME APART AND KNOCKED OUT ONE OF THE PATIENT¿S TOP FRONT INCISORS WHILE ANOTHER INCISOR WAS BARELY HANGING. THE DEVICE HAS TWO SCREWS THAT HOLD IT TOGETHER. ONE WAS NOT SEEN AFTER THE EVENT OCCURRED. UNABLE TO FIND ON GROUND OR ANYWHERE IN OPERATING ROOM. X-RAY CONFIRMED PT DID NOT SWALLOW IT. CHECKED REMAINING 7 MACGYVER RETRACTORS IN STOCK AND SEVERAL OF THEM WITH BOTH SCREWS WOULD COME APART WITH A SLIGHT AMOUNT OF FORCE. BEFORE CHECKING EACH ONE WE TIGHTENED THE SCREWS AND STILL GOT THE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134863 MACGYVER MOUTH RETRACTOR/MCIVOR ACCESSORIES RETRACTOR, DENTAL EIF NOVA SURGICAL, INC. 4553-20
    134864 MACGYVER MOUTH RETRACTOR/MCIVOR ACCESSORIES RETRACTOR, DENTAL EIF NOVA SURGICAL, INC. 4553-20
    134865 MACGYVER MOUTH RETRACTOR/MCIVOR ACCESSORIES RETRACTOR, DENTAL EIF NOVA SURGICAL, INC. 4553-20
    134866 MACGYVER MOUTH RETRACTOR/MCIVOR ACCESSORIES RETRACTOR, DENTAL EIF NOVA SURGICAL, INC. 4553-20
    134867 MACGYVER MOUTH RETRACTOR/MCIVOR ACCESSORIES RETRACTOR, DENTAL EIF NOVA SURGICAL, INC. 4553-20
    134868 MACGYVER MOUTH RETRACTOR/MCIVOR ACCESSORIES RETRACTOR, DENTAL EIF NOVA SURGICAL, INC. 4553-20
    134869 MACGYVER MOUTH RETRACTOR/MCIVOR ACCESSORIES RETRACTOR, DENTAL EIF NOVA SURGICAL, INC. 4553-20
    134870 MACGYVER MOUTH RETRACTOR/MCIVOR ACCESSORIES RETRACTOR, DENTAL EIF NOVA SURGICAL, INC. 4553-20

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR