BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE 3.0S (SP)

    MDR report key: 11028107 · Received December 17, 2020

    Report

    Report Number
    1226420-2020-00170
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 20, 2020
    Report Date
    December 17, 2020
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    GEI
    PMA / PMN Number
    K093695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS SUMMARY: COMPLAINT CONFIRMED: THE COMPLAINT REPORTED WAS ABOUT THE HEAT SHRINK ON THE BLADE THAT SPLIT. UPON OBSERVING THE HEAT SHRINK, IT CAN BE SEEN THE HEAT SHRINK WAS ASSEMBLED OVER THE SHOULDER THAT CAN BE DEFINED/SEEN IN 25-1733. 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 MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT IN A CLINICAL CASE (LEFT TOTAL KNEE REPLACEMENT), THE COATING ON THE HANDPIECE SPLIT IN HALF. THEY CONTINUED THE CASE WITH THE HANDPIECE AS-IS WITH NO NEGATIVE IMPACT TO THE PATIENT. AFTER THE COATING SPLIT THE SITE DID OBSERVE SOME MINOR ARCING FROM THE BLADE. THERE WAS NO IMPACT TO PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498147 PLASMABLADE 3.0S (SP) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY (SALIENT) PS210-030S-SP 2002188

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR