BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE CEV669B DIA 5MM ANG BIPOLAR [MXI/XOM]

    MDR report key: 3667138 · Received March 7, 2014

    Report

    Report Number
    9680837-2014-00013
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Report Date
    February 12, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCTS: TUBE CEV6795B DIA 5MM 350MM, 510K: K993655, LOT#: 140101, MFR DATE: JAN. 2014 TUBE CEV6795B DIA 5MM 350MM, 510K: K993655, LOT#: 131204, MFR DATE: DEC. 2013 BIPOLAR INSERT CEV633-1A 350MM, 510K: K993655, LOT# 140104, MFR DATE: JAN. 2014. (B)(4). THE PRODUCT ANALYSIS DETERMINED THE FOLLOWING: CEV669B HANDLE (QUANTITY 2) THE HANDLES WERE RETURNED DISASSEMBLED. ONE OF THE TWO IS IN SHORT CIRCUIT. A SLIGHT TRACE OF BURN IS OBSERVABLE UNDER THE MICROSCOPE. THE HANDLES MIGHT HAVE BEEN INCORRECTLY ASSEMBLED. HOWEVER, DURING THE CONTROL PHASE, SEVERAL ELECTRICAL TESTS ARE MADE ON THE HANDLES. THE CONTROL INSTRUMENTS USE BIPOLAR CONNECTORS, SIMILAR TO THOSE USED IN OPERATION THEATRES. A CONNECTION FAILURE WOULD MOST LIKELY BE DETECTED. MOREOVER, ONE OF THE HANDLES CAME WITH AN ALMOST TOTALLY UNSCREWED SCREW. THE PROBABILITY OF THIS HANDLE TO PASS THE FINAL CONTROLS IN THIS CONDITION IS VERY LOW. IT APPEARS THAT THE HANDLES HAVE PROBABLY BEEN DISASSEMBLED BY THE CLIENT. THE SHORT CIRCUIT IS PROBABLY THE CONSEQUENCE OF THE PRESENCE OF HUMIDITY IN THE CONNECTION ZONE OF THE HANDLE. CEV6795B TUBE (QUANTITY 2, DIFFERING LOTS): NO ISSUE HIGHLIGHTED. INSTRUMENT CONFORMS TO MANUFACTURING SPECIFICATIONS. CEV633-1A BIPOLAR INSERT (QUANTITY) 2 : THE BIPOLAR CONNECTORS ARE BENT AND TOUCH EACH OTHER. ONE OF THE TWO INSERTS IS IN SHORT CIRCUIT. AN IMPACT IS OBSERVABLE ON THE COATING. THE INSERTS PROBABLY WENT UNDER EXCESSIVE CONSTRAINTS DURING THEIR ASSEMBLY WITH THE HANDLES. THE ORIGIN OF THE SHORT CIRCUIT CANNOT BE DETERMINED WITH CERTAINTY BECAUSE MULTIPLE CAUSES ARE POSSIBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDLE FELL APART DURING REPROCESSING. ON ANALYSIS, IT WAS DISCOVERED THAT ONE OF THE HANDLES HAD A SLIGHT BURN AND WAS ON SHORT CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138901 HANDLE CEV669B DIA 5MM ANG BIPOLAR [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV669B 140103

    Patients

    Seq Age Sex Outcome Treatment
    1