BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE CURVED SHEARS INSERT

    MDR report key: 2870850 · Received December 12, 2012

    Report

    Report Number
    2955842-2012-01258
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 16, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K093217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSERT ACCESSORY AND HARMONIC ACE INSTRUMENT WERE RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSERT ACCESSORY WAS RETURNED INSTALLED ON THE HARMONIC ACE INSTRUMENT. THE INSERT ACCESSORY IS NOT FULLY INSTALLED INTO INSTRUMENT, AS THE INSTRUMENT GEARS ARE NOT MESHING WITH THE INSERT ACCESSORY'S ROUND RACK FEATURE. DISASSEMBLY OF THE INSTRUMENT FOUND THAT THE INSERT IS INCORRECTLY ORIENTED WITHIN THE MAIN TUBE AND THE PEAK ON INSERT ADAPTER IS MAKING CONTACT WITH PEAK ON THE MATING MAIN TUBE FEATURE, THUS PREVENTING PROPER INSTALLATION OF INSERT. THE INSERT PEAK FEATURE SHOULD BE ORIENTED 180 DEGREES FROM THE MAIN TUBE PEAK FEATURE. ENGINEERING EVALUATION ALSO FOUND THAT THE DISTAL END OF THE INSERT IS MISSING THE CLAMP ARM. ONE SIDE OF THE INSERT THAT HOLDS CLAMP ARM PIN IS BENT AND THE HOLE FOR THE PIN IS BROKEN AT ONE EDGE. ENGINEERING CONCLUDED THAT DAMAGE TO THE CLAMP ARM IS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. ON (B)(4) 2012, INTUITIVE SURGICAL CONTACTED (B)(6) (INITIAL REPORTER), THE MATERIALS COORDINATOR AT (B)(6) HOSPITAL IN (B)(6). TINA INDICATED THAT IT WAS NOTED THAT DURING DISASSEMBLY OF THE HARMONIC ACE INSTRUMENT AND INSERT ACCESSORY, THE INSERT ACCESSORY WAS STUCK AND COULD NOT BE REMOVED. (B)(6) INDICATED THAT THERE WAS NO REPORT BY THE SURGICAL STAFF THAT THE DEVICE FAILED DURING THE SURGICAL PROCEDURE AND THAT NO PIECE FROM THE INSERT ACCESSORY WAS REPORTED TO HAVE FALLEN INTO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI SI SURGICAL PROCEDURE, THE SITE WAS UNABLE TO REMOVE THE HARMONIC ACE CURVED SHEARS INSERT ACCESSORY INSTALLED ON THE HARMONIC ACE INSTRUMENT. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE CURVED SHEARS INSERT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400272-02 M10120213

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURGICAL SYSTEM, ACCESSORIES AND ESU.