BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DII CONTROLLER

    MDR report key: 8701310 · Received June 14, 2019

    Report

    Report Number
    1643264-2019-00405
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 31, 2019
    Report Date
    July 30, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRX
    UDI-DI
    03596010607409
    PMA / PMN Number
    K062849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION WAS PERFORMED ON THE PRODUCT AND THE FOOTSWITCH PORT IS BURNT. COMPLAINT OF SMOKING COULD NOT BE REPRODUCED BUT THE FOOTSWITCH PORT HAS A BURNT PIN SLEEVE. THIS COULD HAVE CAUSED THE FOOTSWITCH PORT TO SMOKE. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE HAS BEEN DETERMINED TO BE A BURNT FOOTSWITCH PORT. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS SMOKING. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495370 DII CONTROLLER ARTHROSCOPE HRX SMITH & NEPHEW, INC. 03596010607409

    Patients

    Seq Age Sex Outcome Treatment
    1