BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER MULTIVAC 50 IFS

    MDR report key: 9841821 · Received March 17, 2020

    Report

    Report Number
    3006524618-2020-00113
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    January 20, 2020
    Report Date
    March 17, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00817470004908
    PMA / PMN Number
    K083306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUPER MULTIVAC 50 IFS WAND, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED INCIDENT WAS ESTABLISHED. FROM THE INFORMATION PROVIDED, ¿DURING A KNEE ARTHROSCOPY, THE SUPER MULTIVAC 50 WAS FOUND TO BE BROKEN." A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER 2042993 FOUND NO NON-CONFORMANCE'S OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED 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. DEVICE VISUAL EVALUATION SHOWS THE FLAT SCREEN ELECTRODE IS DETACHED AND NOT AVAILABLE. NO MANUFACTURING DISCREPANCIES OBSERVED. DURING FUNCTIONAL EVALUATION THE FUSE RESISTANCE WAS MEASURED AND REGISTERED 1,505 OHMS PRIOR TO ACTIVATION AND THIS INDICATED A BLOWN FUSE. THE WAND WAS CONNECTED TO A COMPATIBLE CONTROLLER AND REGISTERED AN E-7 ERROR. THE ERROR WAS BY-PASSED AND THE WAND WAS ACTIVATED IN SALINE SOLUTION AT THE DEFAULT AND MAX SETTINGS ON THE CONTROLLER AND PLASMA WAS CREATED ON THE REMAINING ELECTRODE. THE SUCTION LINE WAS TESTED AND PERFORMED AS INTENDED. THE COMPLAINT HAS BEEN VISUALLY VERIFIED AND THE ROOT CAUSE IS ASSOCIATED WITH THE DEVICE POTENTIALLY COMING INTO CONTACT WITH A METAL OBJECT SUCH AS A CANNULA. OTHER FACTORS THAT COULD HAVE LED TO TIP DETACHMENT INCLUDES: MECHANICAL DISPLACEMENT OF TISSUE THROUGH APPLIED FORCE OR USING THE DEVICE AS A LEVER TO ENLARGE A SURGICAL SITE OR GAIN ACCESS TO TISSUE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE SUPER MULTIVAC 50 WAS FOUND TO BE BROKEN. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY WAS REPORTED. RESULTS OF THE INVESTIGATION HAVE CONCLUDED THAT THE WAND'S FLAT-SCREEN ELECTRODE IS DETACHED AND NOT AVAILABLE WHICH INDICATES AN ACTUAL FRAGMENTATION OF THE DEVICE AND THIS MAKES IT A REPORTABLE EVENT. 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
    306320 SUPER MULTIVAC 50 IFS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. ASH4830-01 2042993 00817470004908

    Patients

    Seq Age Sex Outcome Treatment
    1