BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRICUT® STRAIGHT SHAFT 4MM 11CM LONG M4 ROTATABLE

    MDR report key: 6948340 · Received October 13, 2017

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    Report

    Report Number
    1045254-2017-00364
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    August 15, 2017
    Report Date
    September 18, 2017
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    UDI-DI
    20885074079534
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE: -- 1884004HR: BLADE 1884004HR TRICUT 5PK M4 4MM ROTATA, LOT HG1S1KH MANUFACTURED: 2017-04-03, USE BEFORE: 2021-04-03, (B)(4). PRODUCT EVALUATION: ANALYSIS RESULTS ARE NOT AVAILABLE; DEVICES NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT "2 DAYS AFTER FESS SINUS SURGERY" THE PATIENT "BLEW HER NOSE AND A SMALL PIECE OF METAL WAS DISLODGED." THE PIECE APPEARED TO BE THE TIP OF ONE OF THE BLADES USED DURING THE PROCEDURE. NO MALFUNCTION OF EITHER BLADE WAS NOTED DURING OR FOLLOWING THE PROCEDURE, THERE WAS NO DIFFICULT ANATOMY OR MANEUVERING REQUIRED, AND, NO FRAGMENTS WERE SEEN OR FOUND IN THE PATIENT DURING A POST-OP ENDOSCOPY. THE PHYSICIAN IS UNABLE TO CONFIRM WHICH OF THE 2 BLADES USED DURING THE PROCEDURE IS THE ONE THAT BROKE; THERE WAS NO ALLEGED MALFUNCTION ON THE SECOND BLADE. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726716 TRICUT® STRAIGHT SHAFT 4MM 11CM LONG M4 ROTATABLE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC. 1884004HR HG1PVKN 20885074079534

    Patients

    Seq Age Sex Outcome Treatment
    1