BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AE MEDICAL CORP.

    MDR report key: 501695 · Received November 26, 2003

    Report

    Report Number
    MW1030443
    Event Type
    Malfunction
    Date Received
    November 26, 2003
    Date of Event
    October 1, 2003
    Report Date
    November 20, 2003
    Manufacturer
    AE MEDICAL CORP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 7/14/04: THE DEVICE IN QUESTION IS CATALOG NUMBER 050-005 SUCTION COAGULATOR. THIS DEVICE CONSISTS OF AN INSULATED CABLE AND CONNECTOR, MOLDED PLASTIC HANDLE, AND AN INSULATED BRASS CANNULA WITH EXPOSED TIP. IT SERVES AS A CONDUIT TO TRANSMIT ELECTROSURGICAL VOLTAGES FROM A SURGICAL GENERATOR TO THE PT. THE VOLTAGES ARE USED TO CAUTERIZE BODY TISSUE. IN ADDITION, THE DEVICE ALSO PROVIDES A SUCTION PATHWAY FOR FLUID REMOVAL WHEN CONNECTED TO A SUCTION SOURCE. THE "METAL TIP ON THE END OF HANDPIECE" DESCRIBED BY THE USER IS THE EXPOSED TIP OF THE BRASS CANNULA. THE "PLASTIC COVERING" IS A POLYOLEFIN HEAT SHRINKABLE TUBING THAT ELECTRICALLY INSULATES THE REMAINDER OF THE CANNULA BACK TO THE HANDLE. EXAM OF THE RETURNED DEVICE FOUND THAT A PORTION OF THE CANNULA INSULATION NEAR THE EXPOSED TIP HAD EXPANDED AND DISTORTED FROM ITS NORMAL CONDITION. A TRIM LINE PRESENT ON THE BRASS CANNULA UNDERNEATH THE DISTORTED PORTION SUGGESTS THAT THE INSULATION TUBING ON THIS DEVICE WAS ORIGINALLY HEAT SHRUNK AND TRIMMED TO LENGTH, AS THE ASSEMBLY PROCEDURES SPECIFY. AS THE DISTORTED CONDITION OF THE INSULATION WOULD NOT ALLOW THIS DEVICE TO FIT INTO MFR'S IN-PROCESS ELECTRICAL TEST FIXTURE, THE SUBJECT DEVICE WAS NOT SHIPPED IN THIS CONDITION. THE DISTORTION OCCURRED AT SOME POINT AFTER SHIPMENT. EXPOSURE TO AGGRESSIVE SOLVENTS OR ABRASIVE CLEANING TECHNIQUES ARE POSSIBLE CAUSES. HOWEVER, THE EXACT CAUSE IS INDETERMINABLE USING THE FACTS AT HAND. ALL OTHER PRODUCTS IN-HOUSE WITH THE SAME LOT OF INSULATION TUBING WERE EXAMINED AND TESTED. NO INDICATION OF EXPANSION OR DISTORTION WAS FOUND AND ALL SPECIFICATIONS WERE WITHIN ACCEPTABLE LIMITS. MFR HAS HAD NO OTHER REPORTS OF DISTORTED INSULATION FROM END-USERS OR SEEN ANY EVIDENCE OF OTHER DISTORTION IN OUR INTERNAL PROCESSES. THIS IS AN ISOLATED INCIDENT OF UNK ORIGIN, THERE IS NO EVIDENCE OF IMPROPER OR FLAWED DESIGN. EVEN IN THIS CONDITION, THE DEVICE REMAINS SAFE, EFFECTIVE, AND FULLY OPERATIONAL.

    Description of Event or Problem · 1

    METAL TIP ON END OF HANDPIECE HAS PLASTIC COVERING. THIS EXPANDS AND COVERS THE TIP AND MAKES THE HANDPIECE USELESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AE MEDICAL CORP. CANNULA GEI AE MEDICAL CORP STANDARD #10 FR 054C

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other