BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUAMANTYS MBS W/ LIGHT

    MDR report key: 9191993 · Received October 15, 2019

    Report

    Report Number
    1226420-2019-00157
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    September 19, 2019
    Report Date
    December 12, 2019
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    GEI
    UDI-DI
    00643169868205
    PMA / PMN Number
    K073495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS SUMMARY: COMPLAINT NOT CONFIRMED. ANALYSIS FOUND THAT THE DEVICE PASSED THE ELECTRICAL CONTINUITY BUT WAS NOT ABLE TO PROCEED WITH ADDITIONAL FUNCTIONAL TESTS DUE TO THE SALINE TUBE BEING TIED PRIOR TO RECEIVING THE DEVICE. THEREFORE, THE DEVICE CANNOT BE TESTED PROPERLY WITHOUT THE SALINE TUBE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A REPRESENTATIVE (REP) REGARDING A GENERATOR AND HANDPIECES. IT WAS REPORTED THAT DURING A PROCEDURE, THE SITE HEARD A LOUD SPARK AND WAS UNSURE IF IT CAME FROM THE HANDPIECES ATTACHED OR THE GENERATOR. THEY WERE USING A PLASMA BLADE AND AN AQUAMANTYS. THEY CONTINUED USING THE SAME PLASMABLADE, BUT SWITCHED TO ANOTHER AQUAMANTYS HANDPIECE WITH NO KNOWN ISSUES AFTER THAT. THERE WAS NO REPORTED DELAY AND NO IMPACT TO THE PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THEY DID NOT HAVE THE PATIENT'S WEIGHT. IT WAS NOTED THE INFORMATION WAS CONFIRMED WITH THE ACCOUNT/PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985387 AQUAMANTYS MBS W/ LIGHT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY (SALIENT) 23-301-1 PHG269Q0 00643169868205

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR