BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPLASTIC ELECTROSURGICAL DISSECTOR

    MDR report key: 2277596 · Received October 5, 2011

    Report

    Report Number
    1038548-2011-00031
    Event Type
    Injury
    Date Received
    October 5, 2011
    Date of Event
    August 11, 2011
    Manufacturer
    CAREFUSION
    Product Code
    GEI
    PMA / PMN Number
    K930666
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). "THIS MDR WAS PREVIOUSLY SUBMITTED WITHIN THE 30 DAY TIME FRAME BEARING THE REGISTRATION NUMBER OF CARDINAL HEALTH IN ERROR DUE TO A REPORTING SOFTWARE DISCREPANCY. CAREFUSION HAS BEEN ADVISED BY (B)(6) OF THE FDA'S OFFICE OF SURVEILLANCE AND BIOMETRICS IN THE (B)(6) ON (B)(6) 2011, TO RESUBMIT THE MDR BEARING CAREFUSION'S REGISTRATION NUMBER AND TO INCLUDE THIS VERBIAGE WITHIN THE REPORT, AS WELL AS WITHIN CAREFUSION'S COMPLAINT MANAGEMENT SOFTWARE." THE DEVICE WAS NOT RECEIVED FOR EVALUATION AND ADDITIONAL INFORMATION WAS NOT PROVIDED. ALTHOUGH A LOT NUMBER WAS PROVIDED BY THE CUSTOMER, WITHOUT THE RETURNED DEVICE, WE CANNOT VERIFY THE LOT NUMBER TO BE CORRECT. BASED ON LOT NUMBER PROVIDED, A DHR REVIEW WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT INDICATE ANY NON-CONFORMITY THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. WITHOUT THE DEVICE, AND ADDITIONAL INFORMATION A DETERMINATION COULD NOT BE MADE. BY THE DESCRIPTION OF THE ISSUE AND PHOTOS, POSSIBLE REASONS THIS PRODUCT COULD HAVE FAILED: INSULATION HAD A CRACK IN IT PRIOR TO SURGERY AND ATTENDS DID NOT CHECK INSTRUMENTS. AGE OF THE INSTRUMENT. DEVICE WAS DROPPED COULD HAVE CAUSE CRACK. HARSH DETERGENT FOR CLEANING INSTRUMENT COULD HAVE DAMAGE DEVICE INSULATION. SHOULD THE DEVICE BECOME AVAILABLE A NEW ISSUE WILL BE OPENED AND AN INVESTIGATION WILL BE PERFORMED. A TREND WAS REVIEWED FOR PRODUCT CODE 88-5227 FROM 2007 TO CURRENT FOR THE TYPE OF ISSUE REPORTED. NO ISSUES OF THIS TYPE WERE REPORTED FOR PRODUCT CODE 88-5227, THEREFORE NO TRENDS DETECTED.

    Description of Event or Problem · 1

    THE INSULATOR OF THIS DISSECTOR MELTS IN BREAST IMPLANT SURGERY AND THE PATIENT'S SKIN INJURED BY ELECTRIC LEAKAGE. WE HAVE TO RETURN THE DEFECT PRODUCT TO EXCHANGE NEW ONE. (B)(6) 2011: FOLLOW UP INFORMATION REGARDING THE EVENT WAS RELAYED BY (B)(6).  THE DEVICE IN QUESTION HAD BEEN USED FOR 10 MONTHS BY THE FACILITY. A MAMMAPLASTY PROCEDURE WAS UNDERWAY AND THE SURGEON MADE AN INCISION UNDER THE PATIENT'S ARM AREA, AND USED THE PRODUCT TO STOP BLEEDING. THE INSULATION PART FAILED AND THE BLADE WAS PARTLY EXPOSED AND THERE WAS A SPARK WHICH CAUSED A BURN. THE PATIENT WAS TREATED BUT SPECIFICS WERE NOT PROVIDED.  THE MAMMAPLASTY WAS COMPLETED.  THE SURGEON OPENED A NEW ELECTROSURGICAL SCISSOR TO CONTINUE THE PROCEDURE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLASTIC ELECTROSURGICAL DISSECTOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CAREFUSION 88-5227 827190

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention