BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 2003012 · Received February 28, 2011

    Report

    Report Number
    2955842-2011-00059
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K002489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED ONE DISTAL CLEVIS EAR BROKEN OFF AT ITS BASE. THE SIZE OF THE BROKEN PIECE IS APPROXIMATELY .285 X .235. THE EAR HAD BROKEN OFF ON THE OPPOSITE SIDE OF THE CONDUCTOR WIRE AND CAP. THE BROKEN EAR PIECE WAS NOT RETURNED, HOWEVER, THE CONDUCTOR CAP WAS RETURNED TAPED TO THE HOUSING. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE THE END PIECE OF THE PERMANENT CAUTERY SPATULA (PCS) INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED AND THE INSTRUMENT WAS REPLACED WITH ANOTHER PCS INSTRUMENT. THE END PIECE OF THE SECOND PCS INSTRUMENT ALSO BROKE OFF DURING USE AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A THIRD PCS INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. MEDWATCH MFR REPORT 2955842-2011-00060 WAS SUBMITTED FOR THE SECOND PCS INSTRUMENT USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-04 S10080815 943

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR DA VINCI S SURGICAL SYSTEM, ACCS., & ESU