BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAC 70 XTRA COBLATOR II

    MDR report key: 9202437 · Received October 17, 2019

    Report

    Report Number
    3006524618-2019-00516
    Event Type
    Malfunction
    Date Received
    October 17, 2019
    Date of Event
    September 19, 2019
    Report Date
    March 10, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00817470003185
    PMA / PMN Number
    K070374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H3, H6: THE DEVICE USED IN TREATMENT, WAS RETURNED AS AN MDR FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. REVIEW OF COMPLAINT HISTORY OF THE REPORTED LOT NUMBER 2032731 FOR THE PAST 3 YEARS FOUND NO OTHER SIMILAR COMPLAINTS. A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER 2032731 FOUND NO NON-CONFORMANCES OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. THE VISUAL INSPECTION UNDER MAGNIFICATION OF THE WAND SHOWS EXTENSIVE ELECTRODE WEAR WITH STRONG CONTAMINATION/DISCOLORATION AND SCRATCH/SCUFF MARKS ON THE RETURN ELECTRODE AND SPACER. THERE ARE NO MANUFACTURING ABNORMALITIES VISUALLY OBSERVED WITH THE RETURNED WAND. DURING FUNCTIONAL EVALUATION THE DEVICE WAS CONNECTED TO A COMPATIBLE QUANTUM2 CONTROLLER AND DID WORK. THE SUCTION LINE WAS TESTED AND WAS CLOGGED BY DRIED PARTS OF TISSUE; A BACK FLUSH COULD NOT CLEAN THE LINE AND THE SUCTION IS STILL CLOGGED; THE SALINE LINE WAS TESTED AND PERFORMED FLUENTLY AS INTENDED WHEN TESTED ON A SALINE BAG;THE COMPLAINT WAS VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED WITH CERTAINTY. POSSIBLE FACTORS WHICH CONTRIBUTES TO THE REPORTED EVENT ARE: (1) WHEN THE SUCTION LINE BECAME DISCONNECTED, SUCTION PRESSURE MAY HAVE NOT BEEN ENOUGH TO EXCAVATE BLOOD AND TISSUE, OR (2) THERE WAS AN ATTEMPT TO EXCAVATE LARGE ABLATED TISSUE REMNANTS. THESE FACTORS CAN CAUSE THE TIP TO CLOG; THEREFORE, DECREASING THE FUNCTIONALITY OF THE WAND. THERE ARE NO INDICATIONS TO SUGGEST THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND HAD BEEN INTENDED TO BE USED FOR TREATMENT. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THUS, THE COMPLAINT COULD NOT BE VERIFIED, NOR COULD A ROOT CAUSE BE DETERMINED WITH CONFIDENCE. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS EVALUATION WILL BE REOPENED FOR INVESTIGATION. POTENTIAL FACTORS UNRELATED TO THE MANUFACTURING OR DESIGN OF THE DEVICE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDES: 1. ENSURE SUCTION IS PROPERLY CONNECTED, IF NOT, STOP AND CONNECT SUCTION. 2. CONNECT THE SUCTION PORT ON THE WAND TO STANDARD SURGICAL SUCTION. 3. SUCTION PRESSURE/LUMENS AT THE CUSTOMER FACILITY MIGHT NOT BE ABLE TO CLEAN OUT TISSUES BY THE RECOMMENDED VALUE CAUSING A REDUCED PERFORMANCE OF THE DEVICES. THERE ARE NO INDICATIONS TO SUGGEST THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ADENECTOMY SURGERY, THE SUCTION PORT WAS TOTALLY CLOSED, CAUSING A COMPLICATION (BLEEDING) BUT IT WAS CONTROLLED. NO PATIENT INJURIES WERE REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995514 EVAC 70 XTRA COBLATOR II ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. EIC5872-01 2032731 00817470003185

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR