BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR 900-101

    MDR report key: 6099238 · Received November 14, 2016

    Report

    Report Number
    1226420-2016-00179
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 20, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K152596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). RECEIPT OF COMPLAINT INFORMATION TRIGGERED FORMAL INVESTIGATION (B)(4) WHICH IS CURRENTLY IN PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    DURING A BREAST ONCOLOGY CASE, ONE OF THE WIRES BROKE DURING CAPTURE ON THE INTACT WAND. THE WIRE REMAINED ATTACHED TO THE DEVICE TIP. NOTHING REMAINED IN THE PATIENT AND THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 1

    DURING A BREAST ONCOLOGY CASE, ONE OF THE WIRES BROKE DURING CAPTURE ON THE INTACT WAND. THE WIRE REMAINED ATTACHED TO THE DEVICE TIP. NOTHING REMAINED IN THE PATIENT AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751414 GENERATOR 900-101 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC 900-101

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR