BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPES 90, ASPIRATING ABLATOR, TOOTHBRUSH

    MDR report key: 5343889 · Received January 5, 2016

    Report

    Report Number
    1220246-2015-00381
    Event Type
    Injury
    Date Received
    January 5, 2016
    Date of Event
    September 4, 2015
    Report Date
    December 14, 2015
    Manufacturer
    ARTHREX, INC.
    Product Code
    GEI
    PMA / PMN Number
    K023986
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE WAS DISCARDED BY THE FACILITY.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE BLUE COLOR FROM THE WAND CAME OUT AND GOT STUCK TO THE BONE. FOLLOW-UP INVESTIGATION: PROCEDURE WAS A RIGHT ACL RECONSTRUCTION. WHILE PERFORMING THE PROCEDURE ARTHROSCOPICALLY, THE COLOR FROM THE WAND BLED ONTO THE BONE IN THE PATIENT'S KNEE. IT APPEARED THAT THE COLOR CAME FROM THE WAND JUST BELOW THE HEAD OF THE DEVICE. THE COLOR WAS NOT SPECKS/SHAVINGS, IT LOOKED MORE LIKE RUBBING OR LIQUID POSSIBLY. THE TOTAL AREA WAS LIMITED TO 1 SQ INCH AND THE COLOR WAS NOT SOLID IN THIS AREA. THE DEVICE HAS BEEN DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5134 OPES 90, ASPIRATING ABLATOR, TOOTHBRUSH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHREX, INC. 1412071

    Patients

    Seq Age Sex Outcome Treatment
    1 Other