BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT SUPER MULTIVAC 50 IFS

    MDR report key: 10031163 · Received May 6, 2020

    Report

    Report Number
    3006524618-2020-00238
    Event Type
    Malfunction
    Date Received
    May 6, 2020
    Date of Event
    April 14, 2020
    Report Date
    June 23, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00817470006551
    PMA / PMN Number
    K180848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE AMBIENT SUPER MULTIVAC 50 IFS WAND, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. FROM THE INFORMATION PROVIDED, DURING A KNEE ARTHROSCOPY THE AMBIENT SUPER MULTIVAC HAD A E7 ERROR WHEN IT WAS PLUGGED IN. A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED INCIDENT WAS ESTABLISHED. A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER 2032705 FOUND NO NON-CONFORMANCES OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW FOUND NO RELATED FAILURES. VISUAL INSPECTION UNDER MAGNIFICATION OF THE WAND SHOWS MINIMAL ELECTRODE/ SCREEN EROSION WITH CONTAMINATION/DISCOLORATION AND SCRATCH/SCUFF MARKS ON THE SPACER AND RETURN ELECTRODE. NO MANUFACTURING ABNORMALITIES WERE IDENTIFIED. PRIOR TO ACTIVATION R2 WAS MEASURED WITH 1305 OHMS. AFTER BYPASSING THE ERROR E-7 THE DEVICE PRODUCED PLASMA ON ABLATE/COAG MIN./MAX. SETTINGS AS INTENDED. THE SUCTION LINE PERFORMED AS INTENDED. THE COMPLAINT WAS VERIFIED. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER, FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: THE RF CONTROLLER MAY HAVE BEEN TURNED OFF FOLLOWING CONNECTION OF THE WAND OR SOURCE POWER MAY HAVE BEEN INTERRUPTED. THE WAND INCORPORATES A SINGLE-USE FEATURE WHICH IS DESIGNED TO PREVENT REUSE OF THE WAND. THERE ARE OTHER FACTORS THAT COULD CONTRIBUTE TO AN E-7 ERROR SUCH AS DISCONNECTING THE WAND FROM THE CONTROLLER AFTER POWER HAS BEEN TURNED ON, PREVIOUS USE OR INCORRECT POWER CYCLING OF THE CONTROLLER. ALSO, A REPROCESSED WAND USED BY THE CUSTOMER WILL EXHIBIT AN E-7 ERROR. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    FURTHER ASSESSMENT OF INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE INFORMATION STATES THAT NO HARM NOR INJURY WAS REPORTED AND NO PREVIOUS INJURY OR HARM HAS BEEN CONFIRMED TO BE CAUSED BY THE DEVICE IN THE PAST, IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE AMBIENT SUPER MULTIVAC HAD A E7 ERROR WHEN IT WAS PLUGGED IN. THE DEVICE WAS NOT USED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE 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
    492488 AMBIENT SUPER MULTIVAC 50 IFS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. ASHA4830-01 2032705 00817470006551

    Patients

    Seq Age Sex Outcome Treatment
    1