BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT SUPER MULTIVAC 50 IFS

    MDR report key: 9248374 · Received October 28, 2019

    Report

    Report Number
    3006524618-2019-00529
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Report Date
    February 21, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00817470006551
    PMA / PMN Number
    K180848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED AS AN MDR FOR EVALUATION. THERE WAS NO RELATIONSHIP BETWEEN THE RETURNED DEVICE AND THE REPORTED EVENT. REVIEW OF COMPLAINT HISTORY OF THE REPORTED LOT NUMBER 2031594 FOR THE PAST 3 YEARS FOUND NO OTHER SIMILAR COMPLAINTS. A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER 2031594 FOUND NO NON-CONFORMANCES OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. VISUAL INSPECTION UNDER MAGNIFICATION OF THE WAND SHOWS EXTENSIVE ELECTRODE WEAR WITH CONTAMINATION/DISCOLORATION ON THE SCREEN AND SCUFF/SCRATCH MARKS ON THE SPACER AND CAP. THE SCREEN IS HALF DETACHED AND WAS NOT RETURNED WITH THE DEVICE. THE INSULATION AROUND THE SHAFT IS STRONGLY SCRATCHED BUT NOT COMPROMISED AS REPORTED. THERE ARE NO MANUFACTURING ABNORMALITIES VISUALLY OBSERVED WITH THE RETURNED WAND. THE WAND WAS CONNECTED TO A KNOWN GOOD Q2 CONTROLLER AND AN ERROR E7 WAS DISPLAYED. THE ERROR WAS BY-PASSED AND ACTIVATED IN SALINE SOLUTION AT THE DEFAULT AND MAX SETTINGS ON THE CONTROLLER AND PRODUCED PLASMA ON THE REMAINING PARTS OF THE ELECTRODE/SCREEN. THE SUCTION LINE WAS TESTED AND PERFORMED AS INTENDED. THE COMPLAINT WAS NOT VERIFIED AND THE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED WITH CONFIDENCE; HOWEVER, THE REPORTED FAILURE IS CONSISTENT WITH EXTENSIVE WEAR OF THE ELECTRODES WHICH IN TURN WILL DECREASE THE FUNCTIONALITY OF THE WAND. SEVERAL OTHER FACTORS THAT COULD CONTRIBUTE EXTENSIVE ELECTRODE WEAR, SCRATCHED INSULATION OR PARTIAL DETACHED ELECTRODES MAY RESULT FROM VIGOROUS USE AGAINST BONY SURFACES; IRREGULAR WEAR OF THE ELECTRODES LEADING TO MALFUNCTION; ELECTRODES WEAR UNDER USE AND THE RATE OF WEAR ARE DEPENDENT ON VARIABLES THAT CANNOT BE REPLICATED IN ALL CASES. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGERY, THE BLACK LINING DETACHED FROM BIPOLAR END OF THE RF WAND. THIS HAPPENED INSIDE OF THE PATIENT; HOWEVER, IT APPEARS THAT THE SURGEON COULD SATISFACTORILY RETRIEVE THE COMPONENTS OF THE WAND FROM THE PATIENT. A BACK-UP DEVICE WAS AVAILABLE. IT IS UNKNOWN IF THE SURGERY WAS DELAYED. THE PATIENT WAS NOT STATED TO BE HARMED. 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
    1039829 AMBIENT SUPER MULTIVAC 50 IFS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. ASHA4830-01 2031594 00817470006551

    Patients

    Seq Age Sex Outcome Treatment
    1