BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE PS300-002 4PK TNA

    MDR report key: 3223481 · Received July 12, 2013

    Report

    Report Number
    1226420-2013-00130
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 12, 2013
    Report Date
    August 22, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    DWG
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4). INVESTIGATION PLAN: VISUAL INSPECTION DEVICE: PEAK PLASMABLADE TNA PRODUCT P/N: (B)(4) LOT#: 0006612559 EXPIRATION: 2016/01 QUANTITY: 1. THE DEVICE WAS RETURNED IN A (B)(6) SMALL BOX. DEVICE WAS DOUBLE BAGGED IN A BIOHAZARD BAG. RECEIVED THE HAND UNIT, TONSIL TIP WITH MISSING TIP HOUSING, AND ANOTHER TIP HOUSING (BEING FULLY INTACT - PRESUMABLY THE ONE USED TO FINISH THE CASE, SINCE A NEW DEVICE WAS USED TO FINISH THE CASE) WERE SENT BACK WITH TRAY AND TYVEK LID. BOTH TIPS/ELECTRODES HAD INDICATIONS OF BEING USED. TESTING PERFORMED: DID THE DEVICE FAIL TO MEET SPECIFICATION? IF YES, EXPLAIN. USING DIGITAL CALIPERS ((B)(4), CAL DUE: 10/2013) TO MEASURE THE CRITICAL DIMENSIONS OF THE BENDABLE TONSIL TIP, HOUSING (P/N: (B)(4), REV B), THE PART WAS DEEMED IN SPECIFICATION: .255¿ (SPEC: .250¿ +/- .005¿), .201¿ (SPEC: .200 +/- .005¿). THE DIMENSIONAL LENGTH WAS NOT CONFIRMED, SINCE THE DISTAL-MOST TIP FEATURE WAS MISSING, PER THE DESCRIBED COMPLAINT DESCRIPTION. LOT HISTORY RECORD REVIEWED: REVIEWED THE LHR / BATCH RECORD #(B)(4) TO IDENTIFY IF THERE WAS SCRAP RELATED TO THE COMPLAINT. NO SCRAP RELATED TO THE TIP HOUSING. ADDITIONALLY, NO RELEVANT NCMR¿S OR DEVIATIONS. INVESTIGATION CONCLUSION: THE COMPLAINT WAS CONFIRMED. THE PRODUCT ANALYSIS WORK IDENTIFIED THAT THE CHAR ON THE TIP WAS BEING CLEANED WITH A RAYTEC PAD (OR ABRASIVE PAD), INSTEAD OF USING THE CLEANING BRUSH WHICH IS PROVIDED IN THE PACKAGING AND INSTRUCTED PER THE ¿PEAK PLASMABLADE TNA IFU¿ (# (B)(4), REV B). THE ABRASIVE PAD CAN WEAR THE WALL OF THE TIP HOUSING FEATURE. UNDER PEAK PLASMABLADE TNA DEVICE WARNINGS ON PG 1: ¿USE THE CLEANING BRUSH PROVIDED TO REMOVE EXCESS ESCHAR BUILD UP AND MAINTAIN A CLEAR CHANNEL FOR SUCTION.¿ ADDITIONALLY, THE CLEANING BRUSH IFU IS PROVIDED IN THE PACKAGING AND INSTRUCTED PER THE ¿PEAK PLASMABLADE TNA CLEANING BRUSH IFU¿ (# (B)(4), REV C). (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

    INSULATING GREY COVER AT THE END OF TONSIL TIP CAME OFF WHEN CLEANING CHAR OFF OF DEVICE TIP.

    Description of Event or Problem · 1

    INSULATING GREY COVER AT THE END OF TONSIL TIP CAME OFF WHEN CLEANING CHAR OFF OF DEVICE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323631 PLASMABLADE PS300-002 4PK TNA ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY, LLC PS300-002 0006612559

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR