BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2011657 · Received March 9, 2011

    Report

    Report Number
    1056128-2011-00012
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 5, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ASCENT
    Product Code
    NLM
    PMA / PMN Number
    K063788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO ASCENT FOR EVALUATION. AN EXAMINATION OF THE CANNULA REVEALED THAT THE SEALS WERE PROPERLY ORIENTED AND SEATED. THE RETURNED DEVICE WAS TESTED FOR LEAKS TO VERIFY THE CAPABILITY OF THE SEAL TO REMAIN AIRTIGHT WHILE EXPOSED TO AIRFLOW. THE DEVICE PASSED ALL LEAK TESTING. SINCE THE COMPLAINT THAT THE DEVICE LEAKED COULD NOT BE DUPLICATED, THE COMPLAINT COULD NOT BE CONFIRMED. ASCENT'S INSTRUCTIONS FOR USE STATE: "KEEP THE TROCAR STRAIGHT RELATIVE TO THE CANNULA WHEN INSERTING OR REMOVING. IF THE TROCAR IS AT AN ANGLE RELATIVE TO THE CANNULA, IT CAN DAMAGE THE CANNULA AND RESULT IN DESUFFLATION." "SPECIAL CARE SHOULD BE TAKEN DURING INSERTION OF BLADED INSTRUMENTS SO AS NOT TO DAMAGE THE CANNULA VALVE, RESULTING IN DESUFFLATION OF THE OPERATIVE CAVITY." A REVIEW OF THE LOT CONTROL SHEET FOR THE REPORTED DEVICE INDICATED THAT THE INSTRUMENT PASSED ALL APPLICABLE TESTS AND INSPECTIONS PRIOR TO RELEASE. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE TROCAR APPEARED TO BE LEAKING" DURING THE PROCEDURE. VASELINE GAUZE WAS WRAPPED AROUND THE SEAL TO CORRECT THE LEAK AND THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLM NLM ASCENT C0Q01 1296198

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR