BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 1980338 · Received February 7, 2011

    Report

    Report Number
    2955842-2011-00039
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 30, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K002489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. CONFIRMING THE CUSTOMER'S REPORTED COMPLAINT, ENGINEERING FOUND THE INSTRUMENT'S WRIST CABLES AND BACK END CABLES TO BE TIGHT AND INTACT. ADDITIONAL OBSERVATIONS FOUND THE INSTRUMENT'S MAIN TUBE TO BE BROKEN AT THE JUNCTION OF THE PROXIMAL CLEVIS AND MAIN TUBE. THE MAIN TUBE FEATURE WHICH MATES WITH THE PROXIMAL CLEVIS IS BROKEN OFF AND MISSING. BASED ON THESE FINDINGS, ENGINEERING HAS CONCLUDED THAT THE DAMAGE IS LIKELY DUE TO MISUSE AND/OR MISHANDLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI MYOMECTOMY PROCEDURE, THE SURGICAL STAFF OBSERVED SMALL FRAGMENTS IN THE PATIENT'S PELVIS AREA. THE END OF THE PERMANENT CAUTERY HOOK INSTRUMENT WAS NOTED TO BE MISALIGNED WITH PIECES OF THE SHEATH END MISSING. THE FRAGMENTS WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT INSTRUMENT OF THE SAME TYPE. NO PATIENT HARM WAS REPORTED. THE DELAY IN REPORTING IS DUE TO AN ADMINISTRATIVE OVERSIGHT WHERE THE COMPLAINT HANDLING REPRESENTATIVE MISFILED THE REPORT FOR REPORTING THE WEEK AFTER IT WAS DUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-04 S10080930 715

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SURGICAL SYSTEM AND ACCESSORIES