BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE 3.0S

    MDR report key: 6099060 · Received November 14, 2016

    Report

    Report Number
    1226420-2016-00175
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 18, 2016
    Report Date
    March 28, 2017
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K093695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    (B)(4). PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING AN ORTHO CASE, THE HEATSHRINK ON THE PLASMABLADE DEVICE DETACHED. NOTHING FELL INTO THE PATIENT AND THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 1

    DURING AN ORTHO CASE, THE HEATSHRINK ON THE PLASMABLADE DEVICE DETACHED. NOTHING FELL INTO THE PATIENT AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751255 PLASMABLADE 3.0S ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS210-030S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1