BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAC 70 XTRA COBLATOR II

    MDR report key: 9202574 · Received October 17, 2019

    Report

    Report Number
    3006524618-2019-00517
    Event Type
    Malfunction
    Date Received
    October 17, 2019
    Date of Event
    September 19, 2019
    Report Date
    March 13, 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 NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. REVIEW OF COMPLAINT HISTORY OF THE REPORTED LOT NUMBER LOT# 2032731 FOR THE PAST 3 YEARS FOUND NO OTHER SIMILAR COMPLAINTS. A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER LOT# 2032731 FOUND NO NON-CONFORMANCES OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. THE VISUAL INSPECTION UNDER MAGNIFICATION OF THE WAND SHOWS MINIMAL ELECTRODE WEAR WITH CONTAMINATION/DISCOLORATION AND SCRATCH/SCUFF MARKS ON THE RETURN ELECTRODE AND SPACER. DURING FUNCTIONAL EVALUATION THE DEVICE WAS CONNECTED TO A COMPATIBLE QUANTUM2 CONTROLLER AND DID WORK AS INTENDED. THE SUCTION- AND THE SALINE LINE WAS TESTED AND PERFORMED AS SPECIFIED. THE COMPLAINT WAS NOT VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED WITH CERTAINTY. POSSIBLE FACTORS WHICH CONTRIBUTE TO THE REPORTED EVENT ARE: INCLUDES (1)RATE OF ABLATION (2)POWER SETTINGS (3)PROLONGED USE AGAINST DENSE OR BONY SURFACES (4) SUCTION RATE AND (5)FLUID MANAGEMENT. 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: INCORRECT POWER CYCLING OF THE CONTROLLER, OR, THE RF CONTROLLER MAY HAVE BEEN TURNED OFF FOLLOWING CONNECTION OF THE WAND, SOURCE POWER MAY HAVE BEEN INTERRUPTED OR POWER INTERRUPTION TO THE WAND; USED DEFECT CABLING OR DEFECT PERIPHERAL EQUIPMENT OR IMPROPER SALINE FLOW. 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 DEVICE DID NOT WORK PERFECTLY, IT WAS WEAK, CAUSING A COMPLICATION (BLEEDING) BUT IT WAS CONTROLLED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. DELAY GREATER THAN 30 MINUTES WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995238 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