BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE PS300-002 4PK TNA

    MDR report key: 2994389 · Received March 8, 2013

    Report

    Report Number
    1226420-2013-00046
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 6, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY
    Product Code
    DWG
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4) TESTING PERFORMED: VISUAL INSPECTION DEVICE: PEAK PLASMABLADE TNA PRODUCT P/N: PS300-002 LOT# UNKNOWN EXPIRATION UNKNOWN QUANTITY: THE DEVICE WAS RETURNED IN A (B)(4) SMALL BOX. THE DEVICE WAS SINGLE BAGGED IN A 'STERILITY MAINTENANCE COVER' BAG AND WAS SEALED. DEVICE WAS NOT DOUBLE BAGGED AND A BIOHAZARD BAG WAS NOT USED. ONLY THE HAND UNIT/TONSIL TIP WAS SENT BACK. PACKAGE DID NOT INCLUDE ORIGINAL PACKAGE, TYVEK LID, OR ADENOID TIP. THE DEVICE LOT NUMBER FROM (B)(6) COULD NOT BE VERIFIED DUE TO ABSENCE OF TYVEK LID. THE UNIT APPEARS TO HAVE BEEN USED, AS EVIDENCED BY THE CHARRING AND MELTING OF THE TONSIL TIP, AS WELL AS BLOOD SPATTER ON HANDLE. THE PLASMA BLADE HOUSING APPEARS TO HAVE MELTED AND DEFORMED AROUND THE TIP. TIP ALSO APPEARED ABNORMALLY BENT TOWARD THE SUPERIOR SIDE OF THE DEVICE. INVESTIGATION CONCLUSION: THE COMPLAINT WAS CONFIRMED BASED ON VISUAL INSPECTION OF THE TONSIL TIP. PRIOR COMPLAINT HISTORIES AND ROOT CAUSE ANALYSES HAS RESULTED IN (B)(4) BEING OPENED AND A TONSIL TIP MATERIAL CHANGE IS IN PROCESS TO INCORPORATE A TONSIL TIP MATERIAL THAT IS LESS FLAMMABLE IN ELEVATED OXYGEN ENVIRONMENTS. (B)(4).

    Description of Event or Problem · 1

    HALFWAY THROUGH A SURGICAL CASE (TONSILECTOMY) THE PLASMABLADE BLADE TIP SPARKED, WAS QUICKLY REMOVED FROM THE SURGICAL FIELD, AND PLACED IN WATER. NO PATIENT IMPACT AND THE DEVICE WAS REPLACED AND THE CASE CONTINUED. DR. PERFORMING SURGERY STATED THAT THE OR HAS VERY STRONG SUCTION AND DURING THE PROCEDURE THE TIP OF THE DEVICE PARTIALLY ENTERED THE SUCTION TUBE (NOTED BY A WHISTLING NOISE) AND PERHAPS COMPROMISED THE SUCTION CAPABILITY AND POTENTIALLY INCREASED THE OXYGEN LEVEL NEAR THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99788 PLASMABLADE PS300-002 4PK TNA ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY PS300-002 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1