BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE 3.0S

    MDR report key: 6041725 · Received October 19, 2016

    Report

    Report Number
    1226420-2016-00158
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 22, 2016
    Report Date
    September 22, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K093695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    IT WAS REPORTED THIS CUSTOMER HAS BEEN USING PLASMABLADE DEVICES THAT HAVE BEEN RE-STERILIZED BY A 3RD PARTY. IT IS UNKNOWN HOW MANY DEVICES THE HOSPITAL HAD USED, OR WHERE THEY CAME FROM INITIALLY. NO SPECIFIC CASE DETAILS ARE AVAILABLE REGARDING ANY OF THE RE-STERILIZED DEVICES. THE PLASMABLADE DEVICES ARE SINGLE USE DEVICES FO R WHICH RE-STERILIZATION ARE NOT AUTHORIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691777 PLASMABLADE 3.0S ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS210-030S FL50871168

    Patients

    Seq Age Sex Outcome Treatment
    1