BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUAMANTYS 6.0 BIPOLAR SEALER

    MDR report key: 7920246 · Received September 28, 2018

    Report

    Report Number
    1226420-2018-00254
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    August 31, 2018
    Report Date
    September 28, 2018
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    GEI
    PMA / PMN Number
    K052859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #(B)(4):BRIEF DESCRIPTION OF COMPLAINT: DURING SET UP FOR THE CASE, THE STAFF CONNECTED THE HANDPIECE AND THE GENERATOR STARTED DELIVERING AN ACTIVATION TONE AND VISUAL INDICATION (BLUE LIGHT) OF ACTIVATION. THE PRIME BUTTON HAD NOT BEEN PRESSED. THE ACTIVATION BUTTON WAS NOT BEING PRESSED. CUSTOMER IS UNSURE IF ANY ENERGY WAS ACTUALLY BEING DELIVERED TO THE HANDPIECE TIPS. THERE WERE NO ERROR CODES. THE GENERATOR WAS SET TO 170 AND LOW FLOW WHEN THE ISSUE OCCURRED. THE STAFF TRIED PRESSING AND RELEASING THE ACTIVATION BUTTON ON THE HANDPIECE, WITH NO CHANGE. THE STAFF DISCONNECTED THE HANDPIECE AND THE GENERATOR STOPPED INDICATING ACTIVATION; HOWEVER, WHEN THE SAME HANDPIECE WAS RECONNECTED, THE SAME ISSUE OCCURRED. INVESTIGATION CONCLUSION: THE REPORTED ISSUE WAS CONFIRMED. ONCE THE DEVICE WAS PLUGGED IN, THE DEVICE AUTOMATICALLY ACTIVATED WITHOUT DEPRESSION OF THE BLUE ACTIVATION BUTTON, CONFIRMING THE CUSTOMER¿S COMPLAINT. THE WIRES OF THE PCB BOARD WERE FOUND TO HAVE SOLDER DRIFT, AS THE CONNECTION POINTS WHERE ALL THREE WIRES ATTACH TO THE BOARD ARE SHIFTED TO THE LEFT. THE BLUE (BUTTON) WIRE SOLDER POINT IS ALSO TOUCHING THE WHITE WIRE (ELECTRICAL CONTINUITY CIRCUIT) CONTACT POINT, WHICH IS THE CAUSE OF UNINTENDED ACTIVATION UPON INSERTION. PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING SET UP FOR AN ORTHO THA CASE, STAFF REPORTED UPON CONNECTING THE AQUAMANTYS HANDPIECE TO THE AQUAMANTYS GENERATOR, THE GENERATOR STARTED DELIVERING AN ACTIVATION TONE AND VISUAL INDICATION OF ACTIVATION. NEITHER THE PRIME OR ACTIVATION BUTTON HAD NOT BEEN PRESSED. IT IS UNKNOWN IF RF ENERGY WAS ACTUALLY BEING DELIVERED TO THE HANDPIECE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760648 AQUAMANTYS 6.0 BIPOLAR SEALER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY (SALIENT) 23-112-1 PHF058A0

    Patients

    Seq Age Sex Outcome Treatment
    1