BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECTRA SYSTEM REUSABL

    MDR report key: 1781448 · Received August 3, 2010

    Report

    Report Number
    3003604053-2010-00012
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY ANDOVER MANUFACTURING
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT BEING RETURNED FOR EVALUATION.(B)(4)

    Description of Event or Problem · 1

    THERE IS MOISTURE INSIDE THE FIRST USE ENDOSCOPE. IT RESULTED IN AN OPEN PROCEDURE AND NO SCOPE WAS USED TO COMPLETE THE SURGERY. THE SURGEON DID NOT HAVE A BACK UP SCOPE TO PERFORM THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECTRA SYSTEM REUSABL RFB, ENDOSCOPE, 4MM X 30 DEG HRX SMITH & NEPHEW ENDOSCOPY ANDOVER MANUFACTURING 4144F JH466080

    Patients

    Seq Age Sex Outcome Treatment
    1