BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE X 3.0S LIGHT

    MDR report key: 10319196 · Received July 24, 2020

    Report

    Report Number
    1226420-2020-00073
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    July 2, 2020
    Report Date
    July 24, 2020
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    UDI-DI
    00763000279172
    PMA / PMN Number
    K193529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. COMPLAINT WAS NOT CONFIRMED: UPON RECEIVING, ESCHAR BUILDUP WAS VISIBLE, SO THE DEVICE WAS DECONTAMINATED TO PROPERLY OBSERVE AND TO COMPLETE THE ANALYSIS. IT WAS DETERMINED THAT THE COATING ON THE BLADE WAS NORMAL WEAR AND TEAR FROM USING THE DEVICE DURING THE PROCEDURE. THE HEAT SHRINK ON THE DEVICE WAS ASSEMBLED TOO HIGH DEFINED IN 25-1733 WHICH CONTRIBUTED TO THE DEVICE¿S FAILURE. 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 MANUFACTURING REPRESENTATIVE (REP) REGARDING A HANDPIECE. IT WAS REPORTED THAT THE TEFLON COATING CAME OFF THE HANDPIECE. THE HANDPIECE WAS BEING USED TO DISSECT AND COAGULATE TISSUE. THE CASE WAS COMPLETED BY OPENING A NEW HANDPIECE THAT WORKED FINE. IT WAS NOTED THAT THE GENERATOR WAS STILL IN USE. ADDITIONALLY, IT WAS THE DOCTOR FIRST AND ONLY TIME USING IT. THE REP DID NOT KNOW IF THE HANDPIECE WAS BENT. THE REP NOTED THE DOCTOR ONLY USED IT TO DISSECT AND SPOT COAG. HE DID NOT USE THE PICK-UPS. THERE WAS NO VISIBLE RESIDUE LEFT IN THE PATIENT. HE HAD BEEN A USER FOR QUITE A WHILE AND ONLY USES WET LAP TO CLEAN. THE STAFF AT THE FACILITY HAS BEEN TRAINED TO DO THAT OFTEN. THEY DID NOT REPORT ANY UNUSUAL BUILD UP ON THE DEVICE.THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783837 PLASMABLADE X 3.0S LIGHT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS210-030S-LIGHT SM2002111 00763000279172

    Patients

    Seq Age Sex Outcome Treatment
    1