BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE 3.0S

    MDR report key: 11114801 · Received January 4, 2021

    Report

    Report Number
    1226420-2021-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Date of Event
    December 14, 2020
    Report Date
    January 4, 2021
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    GEI
    UDI-DI
    00763000059811
    PMA / PMN Number
    K093695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONFIRMED. THE BLADE WAS OBSERVED AND CONFIRMED THE COATING HAD WEAR AND TEAR FROM THE DEVICE BEING USED. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND FAILED CONTINUITY. THE DEVICE DOES NOT MEET THE PRODUCT SPECIFICATIONS DEFINED IN 31-10-1399 DUE TO THE FUNCTIONALITY FROM CONTINUITY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT TEFLON COATING WAS PEELING OFF TIP. MD REQUESTED REMOVAL FROM THE FIELD. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2826 PLASMABLADE 3.0S ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY (SALIENT) PS210-030S 2001190 00763000059811

    Patients

    Seq Age Sex Outcome Treatment
    1