BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM]

    MDR report key: 3418005 · Received October 18, 2013

    Report

    Report Number
    9680837-2013-00484
    Event Type
    Injury
    Date Received
    October 18, 2013
    Date of Event
    September 19, 2013
    Report Date
    September 25, 2013
    Manufacturer
    XOMED MICROFRANCE ENGINEERING
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. DEVICE INFO: LOT NUMBER UNKNOWN. CONCOMITANT DEVICES: CEV605G - SCISSORS INSERT CEV605G 3PK 350MM, LOT 120702. MANUFACTURED 07-2012; CEV1039G5 - HANDLE CEV1039G5 DIA 5MM ANG INSULATED, LOT 101001. MANUFACTURED 10-2010. (B)(4). PRODUCT EVALUATION: PRODUCT ANALYSIS FOUND THAT THE INSULATION OF THE TUBE (CEV 649-5B) RETURNED IS BURNT AT THE SCREW THREAD LEVEL AT DISTAL END. THE I NSULATION IS NOT THE ORIGINAL ONE. THE DIMENSIONS AND THE MATERIAL OF THE INSULATION ARE NOT CONFORMING AND DO NOT COMPLY WITH OUR MANUFACTURING SPECIFICATIONS. THE INSULATION OF THE RETURNED TUBE HAS BEEN MODIFIED BY A CONTRACTOR NOT QUALIFIED BY MEDTRONIC. THIS MODIFICATION IS VERY LIKELY THE ORIGIN OF THE REPORTED INCIDENT WHICH IS THE CONSEQUENCE OF NON-CONFORMING AND TOO SHORT INSULATION WHICH HAS LED TO AN INSULATION FAULT AND AN ELECTRIC ARC. THE BLACK PLASTIC SLEEVE (CEV605G) IS BURNT AT ITS EXTREMITY, WHICH IS IN CONTACT WITH THE TUBE (ONCE ASSEMBLED). THE BLADES PRESENT SOME TRACES OF IMPACT. THE BURN ON THE PLASTIC IS THE CONSEQUENCE OF THE FORMATION OF AN ELECTRIC ARC RESPONSIBLE FOR THE REPORTED INCIDENT. THE ORIGIN OF THE ELECTRIC ARC IS PROBABLY THE INSULATION FAULT FROM THE TUBE MODIFIED OUTSIDE MEDTRONIC. THE HANDLE (CEV1039G5) WAS RETURNED WITH THE TUBE AND INSERT. NO FUNCTIONING ISSUE DETECTED. STANDARD MAINTENANCE REPAIR NECESSARY; RETURNED TO CUSTOMER. DURING ANALYSIS, THIS DEVICE WAS PROVEN TO BE REMANUFACTURED BY A CONTRACTOR OUTSIDE OF MEDTRONIC; THEREFORE WE ARE NO LONGER CONSIDERED TO BE THE DEVICE MANUFACTURER. BECAUSE WE CANNOT EFFECTIVELY IDENTIFY WHO MODIFIED THE DEVICE WE ARE SUBMITTING THIS MDR IN DUE DILIGENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REPORTED AN ELECTRICAL ARC DURING SURGERY. AS A RESULT, THE PATIENT RECEIVED AN INTESTINAL BURN WHICH REQUIRED A RESECTION. THE SURGERY COULD GO ON BUT THERE IS NO CURRENT INFORMATION ON THE PATIENT¿S HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534750 TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE ENGINEERING CEV649-5B

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention