BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE ADENOID

    MDR report key: 6443059 · Received March 29, 2017

    Report

    Report Number
    1226420-2017-00113
    Event Type
    Malfunction
    Date Received
    March 29, 2017
    Date of Event
    February 28, 2017
    Report Date
    February 28, 2017
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K152703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #(B)(4): BRIEF DESCRIPTION OF COMPLAINT: PLASMABLADE¿ ADENOID - SPARK - GUNKING - TNA - FAILURE TO CONNECT - THE DEVICE FAILED TO CONNECT TO THE GENERATOR. A SECOND DEVICE WAS USED AND THE SURGEON REPORTED GUNKING AND A SPARK FROM THE ADENOID TIP. INVESTIGATION PLAN: VISUAL INSPECTION FUNCTIONAL INSPECTION (IF APPLICABLE) LHR REVIEW COMPLAINT DEVICE DETAILS: DEVICE # 1: FAILURE TO CONNECT; DEVICE NAME: PLASMABLADE¿ TNA; PRODUCT NUMBER: PS300-002; LOT NUMBER: 0212200368; EXPIRATION DATE: 14-NOV-2019; QUANTITY RETURNED: 1. DEVICE # 2: ADENOID TIP GUNKING - SPARK; DEVICE NAME: PLASMABLADE¿ ADENOID; PRODUCT NUMBER: PS300-003 - NEW DESIGN; LOT NUMBER: UNKNOWN; EXPIRATION DATE: UNKNOWN; QUANTITY RETURNED: 1. TESTING PERFORMED: DEVICE PACKAGING INSPECTION: ONE RETURNED PLASMABLADE¿ TNA DEVICE HANDLE WITHOUT AN ATTACHMENT TIP AND ONE ADENOID TIP WITHOUT THE DEVICE HANDLE WAS RECEIVED INSIDE A FEDEX SHIPPER BOX NOT WITHIN BIOHAZARD BAGS WITH PAPER TO FILL THE NEGATIVE SPACE. THE DEVICES WERE LABELED AS DEVICE # 1 AND DEVICE # 2 FOR TRACEABILITY. DEVICE # 1: THE DISPLAY BOX AND THE TYVEK® LID WERE RETURNED; THE DEVICE INFORMATION WAS CONFIRMED AGAINST THE INFORMATION LISTED WITHIN GCH FROM THE DISPLAY BOX AND THE TYVEK® LID. DEVICE # 2: THE ADENOID TIP WAS RECEIVED INSIDE A SURGICAL GLOVE WITHIN A BIOHAZARD BAG WITH NO ORIGINAL PACKAGING THEREFORE, IT IS NEITHER POSSIBLE TO CONFIRM THE DEVICE INFORMATION AGAINST THE INFORMATION LISTED WITHIN GCH, THE LOT NUMBER IS LISTED AS UNKNOWN WITHIN GCH, NOR CONFIRM THE ADENOID TIP THAT WAS SENT BACK AS THE REPORTED COMPLAINT ADENOID TIP. THERE WAS NO PAPERWORK PROVIDED. DEVICE VISUAL INSPECTION: DEVICE # 1: FAILURE TO CONNECT. THE DEVICE APPEARS CLEAN AND UNUSED. THERE ARE BENT, FLATTENED AND SHEARED PLUG CONNECTOR PINS WHICH VISUALLY RELATE TO THE REPORTED COMPLAINT DESCRIPTION, ALL OTHER COMPONENTS APPEAR IN PLACE AND INTACT. THE DEVICE PLUG CONNECTOR SUPPLIER IS (B)(4). DEVICE # 2: ADENOID TIP GUNKING - SPARK. THE ADENOID TIP ELECTRODE WIRE, PLASTIC HOUSING, AND SUCTION OPENING CONTAIN TISSUE AND COAGULUM BUILDUP, WHICH VISUALLY RELATES TO THE REPORTED COMPLAINT DESCRIPTION, ALL OTHER COMPONENTS APPEAR IN PLACE AND INTACT, IMAGE # 1 THRU IMAGE # 6. THERE IS A MODERATE AMOUNT OF TISSUE AND COAGULUM BUILDUP ON THE ELECTRODE WIRE, WITH THE MINOR MELTING OF THE PLASTIC HOUSING AT THE CORNERS, HOWEVER, THE ELECTRODE WIRE REMAINS INTACT WHICH MEETS THE ACCEPTABLE DAMAGE REQUIREMENTS. ALL ELECTROSURGICAL DEVICES EXHIBIT WEAR DURING USE AND WEAR IS ACCEPTABLE IF IT DOES NOT AFFECT THE SAFETY OF THE DEVICE. THE EFFICACY OF THE DEVICE IS NOT AFFECTED BY THE DAMAGE EXHIBITED ON THE DEVICE. THE DEVICE AND ADENOID TIP WERE CLEANED AND THE ¿TEST METHOD PROCEDURE FOR ADENOID TIP¿ WAS UTILIZED TO DETERMINE IF THE WEAR OF THE WIRE ELECTRODE AND PLASTIC HOUSING IS ACCEPTABLE, IMAGE # 3 THRU IMAGE # 6. ACCEPTABLE DAMAGE: ADENOID TIP: THE WIRE REMAINS INTACT <(><<)>(><(><<)><(><<)>)> 33% OF THE ¿WIRE SQUARE¿ IS EXPOSED. THE WIRE STILL HAS SUPPORT FROM THE HOUSING AND DOES NOT EXHIBIT DEFORMATION IN THE VENTRAL TO DORSAL DIRECTION DURING APPLICATION. THE MELT-BACK IS NOT WISPY OR STRINGY IN APPEARANCE. UNACCEPTABLE DAMAGE: ADENOID TIP. THERE IS NO UNACCEPTABLE WEAR ON THE RETURNED ADENOID TIP. INSUFFICIENT CLEANING, TECHNIQUE, AND USE CONTRIBUTE TO THE TISSUE AND COAGULUM BUILDUP ON THE ELECTRODE WIRE AND PLASTIC HOUSING WHICH CAN DIMINISH DEVICE PERFORMANCE, COMPROMISE THE PLASTIC HOUSING AND ELECTRODE WIRE AND CAN CONTRIBUTE TO THE CLOGGING OF THE SUCTION OPENING. SEE THE REFERENCE PICTURE OF AN ADENOID TIP - NEW DESIGN FOR COMPARISON, IMAGE # 7 AND IMAGE # 8. THE COMPLAINT COULD NOT BE RECREATED FOR THE DEVICE SPARKING ISSUE THAT WAS REPORTED IN THE COMPLAINT DESCRIPTION; HOWEVER, ACTIVATING THE DEVICE OUTSIDE THE FIELD OF TISSUE CAN CREATE ARCING WHICH CAN CAUSE THE GAP BETWEEN THE TISSUE AND THE DEVICE IN THE FIELD TO CREATE SPARKING. FUNCTIONAL INSPECTION: DEVICE # 1: FAILURE TO CONNECT. THE RETURNED PLASMABLADE¿ TNA DEVICE PLUG CONNECTOR WAS INSERTED INTO THE RECEPTACLE ON THE COMPLAINT LAB PULSAR¿ II GENERATOR, HOWEVER, THE DEVICE FAILED TO CONNECT TO THE GENERATOR SUCCESSFULLY. THE GENERATOR SCREEN DISPLAYED DASHES FOR SETTINGS AND THERE WAS NO AUDIBLE TONE HEARD COMING FROM THE GENERATOR WHICH CONFIRMS A SUCCESSFUL CONNECTION WAS NOT DEMONSTRATED. THE DAMAGED PLUG CONNECTOR PINS WHICH ARE BENT, FLATTENED AND SHEARED ALONG WITH MISALIGNED PINS PREVENT CONNECTION TO THE GENERATOR, ALL SIX PINS, IMAGE # 9. DEVICE # 2: ADENOID TIP GUNKING - SPARK. THE FUNCTIONAL INSPECTION PORTION OF THIS COMPLAINT INVESTIGATION WAS NOT PERFORMED AS THE COMPLAINT WAS CONFIRMED VIA VISUAL INSPECTION. LHR REVIEW: DEVICE # 1: A REVIEW OF THE LHR FOR LOT # 0212200368 REVEALED THERE WERE NO PROBLEMS DURING MANUFACTURING THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT DESCRIPTION. DEVICE # 2: A REVIEW OF THE LHR IS NOT POSSIBLE BECAUSE THE LOT NUMBER IS LISTED AS UNKNOWN WITHIN GCH AND THERE WAS NO ORIGINAL PACKAGING RETURNED TO OBTAIN THE DEVICE INFORMATION. INVESTIGATION CONCLUSION: COMPLAINT CONFIRMED: THIS COMPLAINT WILL BE TRACKED AND TRENDED WITHIN GCH. DEVICE # 1: THE DEVICE FAILED TO SUCCESSFULLY CONNECT TO THE GENERATOR DUE TO BENT AND MISALIGNED PLUG CONNECTOR PINS. DEVICE # 2: THE COMPLAINT IS CONFIRMED FOR THE CLOGGING AND GUNKING ISSUE THAT THE CUSTOMER REPORTED. THE ADENOID TIP EXHIBITS WEAR, HOWEVER, THE WEAR IS INDICATIVE OF USE AND MEETS THE ACCEPTABLE DAMAGE REQUIREMENTS. THE COMPLAINT IS NOT CONFIRMED FOR THE DEVICE SPARKING ISSUE WHICH COULD NOT BE RECREATED. ADDITIONALLY, IT WAS FOUND THAT THE ADENOID TIP HOUSING IS MELTED, HOWEVER, THE WEAR EXHIBITED MEETS THE ACCEPTABLE DAMAGE REQUIREMENTS. NOTE: THE RETURNED ADENOID TIP IS FROM THE NEW DESIGN. REFERENCE DOCUMENTS: 42-10-1020 REV. H - WORK INSTRUCTIONS FOR COMPLAINT INVESTIGATIONS - DISPOSABLE DEVICES 31-10-1370 REV. J - PRODUCT SPECIFICATION AND QUALITY PLAN - TNA PRODUCT FAMILY 70-10-1447 REV. C - PEAK PLASMABLADE¿ TNA - IFU 70-10-1433 REV. C - PULSAR¿ II GENERATOR OPERATOR¿S MANUAL 61-10-0017 REV. H - DEVICE BUTTON TACTILE TEST PROCEDURE 61-90-0700 REV. D - TEST METHOD PROCEDURE FOR ADENOID TIP TEST EQUIPMENT: EQP # - EQP - NAME - MANUFACTURER 6794 - PULSAR¿ II - GENERATOR PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER.

    Description of Event or Problem · 1

    DURING AN ENT CASE, THE SURGEON REPORTED A SPARK FROM THE PLASMABLADE DEVICE TIP. THERE WAS NO IMPACT TO THE PATIENT OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226630 PLASMABLADE ADENOID ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS300-003 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1