BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1850579 · Received October 1, 2010

    Report

    Report Number
    1056128-2010-00061
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 23, 2010
    Manufacturer
    ASCENT
    Product Code
    KCY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EXAMINED AND AN INITIAL INSPECTION DID NOT IDENTIFY ANY HOLES, TEARS, PUNCTURES, OR OBVIOUS DEFECTS THAT COULD RESULT IN A POTENTIAL LEAK BUT FUNCTION TESTING REVEALED A LEAK AT ONE TUBE TO PORT CONNECTION. A REVIEW OF THE LOT CONTROL SHEETS FOR THIS DEVICE CONFIRMED THE DEVICE PASSED ALL FUNCTION TESTING BEFORE LEAVING ASCENT. THE MOST LIKELY CAUSE OF THE DEVICE FAILURE HAPPENED AFTER THE DEVICE WAS SHIPPED POSSIBLY FROM AGGRESSIVE HANDLING OF THE DEVICE TUBING/PORT CONNECTIONS DURING USE. DUE TO THE INFREQUENCY OF THIS TYPE OF EVENT, NO TREND ANALYSIS IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOURNIQUET CUFF WOULD NOT INFLATE DURING THE PROCEDURE. THE PHYSICIAN DECIDED NOT TO REPLACE THE DEVICE AND PERFORMED THE PROCEDURE USING THIS DEVICE. THE PROCEDURE TIME WAS EXTENDED FOR APPROXIMATELY 30 MINUTES DUE TO EXTRA SPONGES AND LAPAROSCOPIC DEVICES BEING USED DURING THE CASE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A KCY KCY ASCENT 60-7070-106 1210975

    Patients

    Seq Age Sex Outcome Treatment
    1