BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUAMANTYS MBS W/ LIGHT

    MDR report key: 8642702 · Received May 24, 2019

    Report

    Report Number
    1226420-2019-00101
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    February 4, 2019
    Report Date
    May 30, 2019
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    GEI
    UDI-DI
    00763000047450
    PMA / PMN Number
    K073495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS STIPULATED IN 21 CFR 803. 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

    ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP) REPORTED THE PUMP ON THE GENERATOR WAS NOT SUPPLYING SALINE. "THE" STATED THE HANDPIECES WERE ACTIVATED TO MAKE SURE THEY WORKED BEFORE USING THEM ON THE PATIENT. THE REP NOTED HE DID NOT BELIEVE IT WAS OPERATOR ERROR, BUT RATHER THE PUMP BEING BROKEN AND NOT SUPPLYING SALINE. THE REP CLARIFIED THERE WAS NO "SMOKE" BUT STEAM. IT WAS NOTED THE GENERATOR WAS STILL AT THE FACILITY NOT IN USE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR AND HANDPIECE USES IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT WHEN INITIALLY ACTIVATED THE DEVICE EMITTED A LOUD POPPING SOUND AND BEGAN SMOKING IN THE SURGEON¿S HANDS. IT WAS NOTED THIS HAPPENED WITH 2 DEVICES, A THIRD DEVICE WAS OPENED BUT THE PHYSICIAN DECLINED TO ACTIVATE THE DEVICE DUE TO THE PERFORMANCE OF THE OTHER TWO DEVICE. ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL. IT WAS REPORTED THAT THE INCIDENT WAS INVESTIGATED BY LOCAL MANUFACTURER REPRESENTATIVE (REP), WHO ASCERTAINED IT WAS THE RESULT OF OPERATOR ERROR. THE HCP NOTED THE PRODUCT DID NOT COME IN CONTACT WITH THE PATIENT AT ANY TIME AND THE EFFECTED WAS TAKEN BY THE VENDER REP. ADDITIONAL INFORMATION FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THE EVENT HAPPENED ON (B)(6) 2019 AND THEY WERE MADE AWARE THAT SAME DAY. THE REP NOTED THEY MET WITH THE ACCOUNT AND THE SURGEON ON (B)(6), THE PUMP ON THE GENERATOR MALFUNCTIONED AND WAS NO LONGER PROVIDING SALINE TO THE TIP OF THE DEVICE. THE REP NOTED THE GENERATOR HAD BEEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435830 AQUAMANTYS MBS W/ LIGHT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY (SALIENT) 23-301-1 PHG318E0 00763000047450

    Patients

    Seq Age Sex Outcome Treatment
    1