BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE 4.0 GENERAL SURGERY

    MDR report key: 2981208 · Received February 27, 2013

    Report

    Report Number
    1226420-2013-00037
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    DWG
    PMA / PMN Number
    K073057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. RESULTS: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. CONCLUSION: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. PRODUCT EVENT: (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT# (B)(4) TESTING PERFORMED: VISUAL INSPECTION DEVICE: PEAK PLASMABLADE 4.0 DEMO PRODUCT P/N: PS200-040DEMO LOT# 52327 QTY: 1 RETURNED IN BAG AND (B)(4) LETTER-SIZED ENVELOPE. RETURNED IN SINGLE DEMO PLASTIC BAG - PRODUCT WAS NOT DOUBLE BAGGED OR PACKAGED IN BIOHAZARD BAG. DEVICE HAD NO EVIDENCE OF USE (I.E. BLOOD, TISSUE, ETC.) ON THE TIP, SHAFT, OR HANDLE. ALL COMPONENTS WERE INTACT AND THERE WERE NO MISSING PARTS. FUNCTIONAL INSPECTION DEVICE WAS CONNECTED TO A PULSAR II GENERATOR (PS100-102), EQP# 6794 (CALIBRATION DUE DATE: 09/2013) THE DEVICE WAS ACTIVATED IN GROUNDED SALINE AT CUT SETTING 10 AND COAG SETTING 10 AND FUNCTIONED AS INTENDED. INVESTIGATION CONCLUSION: DETERMINE RELATIONSHIP, IF ANY, OF THE DEVICE TO THIS REPORTED INCIDENT THIS INVESTIGATION WAS PERFORMED ON THE PLASMABLADE 4.0 DEMO DEVICE THAT WAS ALSO ASSOCIATED WITH THE GENERATOR INTERFERENCE WITH OTHER EQUIPMENT. THIS INVESTIGATION CONFIRMED THE DEVICE FUNCTIONED AS INTENDED. SYSTEM APPROACH: THE RF ENERGY IS GENERATED VIA THE GENERATOR AND DELIVERED TO THE DEVICE FOR UTILIZATION AND THE DEVICE DOES NOT GENERATE THE RF ENERGY ON ITS OWN. VIA THE PRODUCT ANALYSIS IT WAS DETERMINED THAT THE UNIT WAS DELIVERING RF ENERGY CORRECTLY INTO THE FIXED RESISTORS AND THE DEVICE FUNCTIONED AS INTENDED. THEREFORE, IF RF ENERGY WAS BEING DELIVERED PROPERLY IT IS LIKELY THE SET-UP OR ENVIRONMENTAL CONDITIONS OF THE OR CONTRIBUTED TO THE INCIDENT RATHER THAN A FAILURE OF THE PRODUCTS INVOLVED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING DEMONSTRATION: ACTIVATION OF COAGULATION MODE WOULD SHUT DOWN EKG MONITOR AND REQUIRE RE-BOOT AND WHEREAS CUT FUNCTION WOULD CREATE INTERFERENCE BUT WOULD NOT SHUT DOWN EKG MONITOR. SWAPPING PULSAR II GENERATOR FOR PULSAR I RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    DURING DEMONSTRATION: ACTIVATION OF COAGULATION MODE WOULD SHUT DOWN EKG MONITOR AND REQUIRE RE-BOOT AND WHEREAS CUT FUNCTION WOULD CREATE INTERFERENCE BUT WOULD NOT SHUT DOWN EKG MONITOR. SWAPPING PULSAR II GENERATOR FOR PULSAR I RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84338 PLASMABLADE 4.0 GENERAL SURGERY ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY, LLC PS200-040 52327

    Patients

    Seq Age Sex Outcome Treatment
    1