BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER TURBOVAC 90 ICW

    MDR report key: 9527854 · Received December 27, 2019

    Report

    Report Number
    3006524618-2019-00625
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    November 29, 2019
    Report Date
    February 19, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00817470006421
    PMA / PMN Number
    K033584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. VISUAL INSPECTION UNDER MAGNIFICATION OF THE WAND SHOWS MINIMAL ELECTRODE WEAR WITH DISCOLORATION/CONTAMINATION ON THE SCREEN AND SCRATCH/SCUFF MARKS ON THE SPACER, SCREEN AND CAP. THERE ARE NO MANUFACTURING ABNORMALITIES VISUALLY OBSERVED WITH THE RETURNED WAND. THE DEVICE WAS CONNECTED TO A COMPATIBLE QUANTUM2 CONTROLLER AND WAS ACTIVATED IN SALINE SOLUTION AT THE DEFAULT AND MAX SETTINGS ON THE CONTROLLER AND PERFORMED AS INTENDED. THE SUCTION LINE WAS TESTED AND AS REPORTED WAS CLOGGED. A BACK FLUSH COULD CLEAN THE LINE AND THE SUCTION PERFORMED AS INTENDED. THE COMPLAINT WAS VERIFIED AND THE ROOT CAUSE WAS DETERMINED TO BE ASSOCIATED WITH THE CLOGGED SUCTION LINE. IT IS POSSIBLE THAT THE SUCTION LINE WAS NOT PROPERLY CONNECTED OR THE SUCTION PRESSURE AT THE CUSTOMER¿S FACILITY MAY HAVE NOT SUPPLIED ENOUGH PRESSURE IN ORDER TO EXCAVATE BLOOD AND TISSUE. WHEN THE RECOMMENDED SUCTION PRESSURE IS NOT USED, THIS WILL CAUSE THE SUCTION LINE TO CLOG; THEREFORE, DECREASING THE FUNCTIONALITY OF THE WAND. THE INSTRUCTION FOR USE (¿IFU¿) CONTAINS WARNINGS AND PRECAUTIONARY STATEMENTS REGARDING MAINTAINING PROPER SUCTION FLOW .A DHR/BATCH RECORD REVIEW FOR LOT 2031844 FINDING NO DISCREPANCIES FROM RELEASED AND OPERATING PROCEDURES OR CONDITIONS THAT COULD CONTRIBUTE TO THE EVENT. THE REVIEW OF THE COMPLAINT HISTORY FOR THE ASSOCIATED COMPLAINT PRODUCT FOUND NO SIMILAR EVENTS IN THE LAST THREE YEARS FOR THE INVOLVED LOT. THIS COMPLAINT WILL BE RECORDED FOR TRACKING AND TRENDING PURPOSES. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW 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 A KNEE ARTHROSCOPY, THE SUPER T-VAC WAS NOT PROPERLY WORKING DESPITE AN INCREASE IN THE POWER, IT WAS NOT EFFECTIVELY CLEANING THE JOINT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. A DELAY OF MORE THAN 30 MINUTES WAS REPORTED. NO PATIENT INJURY 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
    1321074 SUPER TURBOVAC 90 ICW ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. ASC4250-01 2031844 00817470006421

    Patients

    Seq Age Sex Outcome Treatment
    1