BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERV REPL, HD COUPLER, 19.5MM

    MDR report key: 6084162 · Received November 7, 2016

    Report

    Report Number
    3003604053-2016-00107
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 17, 2016
    Report Date
    July 5, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    FEI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS WERE PERFORMED WHICH CONFIRMED NO INCONSISTENCIES.

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED BY THE SMITH & NEPHEW AND COULD CONFIRM THE CUSTOMER COMPLAINT FOR THE DEVISE HAVING A BROKEN PART. A VISUAL INSPECTION WAS PREFORMED AND SHOWED THE COUPLER HAS BEEN USED IN FIELD. THIS DEVICE WAS SHIPPED TO THE CUSTOMER IN 2011. THE EYEPIECE IS CRACKED EXPOSING THE O-RING. THIS IS CAUSED BY HARD CONTACT TO THE EYEPIECE. NO MANUFACTURING RELATED DEFECTS WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD BROKEN PARTS. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732526 SERV REPL, HD COUPLER, 19.5MM INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE FEI SMITH & NEPHEW, INC. BBB2125

    Patients

    Seq Age Sex Outcome Treatment
    1