BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX RETRATOR

    MDR report key: 5986621 · Received September 29, 2016

    Report

    Report Number
    5986621
    Event Type
    Malfunction
    Date Received
    September 29, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 16, 2016
    Manufacturer
    MEDROBOTICS CORPORATION
    Product Code
    KAL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HERE FOR ROBOTIC ASSISTED SURGICAL REPAIR OF EPIGLOTTOPLASTY. POSITIONED PATIENT'S MOUTH OPEN FOR PROCEDURE WITH MEDROBOTICS FLEX RETRACTOR BY SURGEONS. AT END OF PROCEDURE WHEN RETRACTOR WAS REMOVED A SMALL OPEN AREA ON CHIN WAS DISCOVERED WHERE RETRACTOR HAD BEEN AGAINST. CLOSED WITH SUTURE BY SURGEONS AND BACITRACIN OINTMENT APPLIED. PICU RN NOTIFIED. MANUFACTURER RESPONSE FOR FLEX RETRACTOR, MEDROBOTICS FLEX RETRACTOR (PER SITE REPORTER): THE MEDROBOTICS REPRESENTATIVE IS AWARE OF THE SURGEON HAVING THE DEVICE AT PRESENT. THE REPRESENTATIVE'S NAME CAN BE MADE KNOWN TO THE COMPANY AS NEEDED (NOT AVAILABLE WHEN THIS MEDSUN WAS FILED). THE DEVICE WAS TAKEN BY THE REP AND USED AT ANOTHER FACILITY OUTSIDE OF OUR PARENT COMPANY IN MASSACHUSETTS. THE COMPANY HAS POSSESSION OF THE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638898 FLEX RETRATOR RETRACTOR, ENT - FLEX RETRACTOR KAL MEDROBOTICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other NO OTHER THERAPIES| SEE OPERATING ROOM PROCEDURE DESCRIBED BELOW