BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE CLIP APPLIER INSTRUMENT

    MDR report key: 3230506 · Received July 16, 2013

    Report

    Report Number
    2955842-2013-02573
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 11, 2013
    Report Date
    July 23, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT AND/OR ACCESSORY HAVE NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION), OR IF ADDITIONAL INFORMATION IS RECEIVED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT. UPON VISUAL INSPECTION, ENGINEERING FOUND NO BROKEN COMPONENTS AT THE DISTAL END. THE GRIPS OPENED AND CLOSED WHEN THE INPUTS WERE MANUALLY ROTATED. ENGINEERING OBSERVED THAT THE INSTRUMENT LUER PLATE WAS DISLODGED FROM THE CHASSIS AND PUSHED INTO THE BACKEND. A SECTION OF THE CHASSIS INNER WALL FEATURE THAT HELD THE LUER PLATE WAS BROKEN OFF. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGE WAS LIKELY DUE TO IMPROPER CLEANING. ENGINEERING FOUND THE CLAMPING PULLEY WAS CRACKED ON THE SCREW HEAD SIDE. THE SCREW HAD LOOSENED DUE TO THE CRACKING. ALL THE CLAMPING PULLEYS EXHIBITED WHITE RESIDUE AROUND THE CABLE GROOVES. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGE WAS LIKELY DUE TO IMPROPER CLEANING. NO OTHER DAMAGE WAS FOUND. THE CLEANING AND STERILIZATION USER MANUAL SPECIFICALLY STATES: O WHEN SCRUBBING THE TIP OF CAUTERY INSTRUMENTS, TAKE CARE NOT TO DAMAGE THE INSULATION. O DO NOT EXPOSE INSTRUMENTS TO HYDROGEN PEROXIDE (H2O2), BLEACH, OR ALKALINE-BASED CLEANING AGENTS, AS THIS MAY RESULT IN INSTRUMENT DAMAGE. O PROLONGED EXPOSURE TO EITHER ULTRASONIC CLEANING OR CLEANING AGENTS MAY RESULT IN INSTRUMENT DAMAGE. RECURRENCE OF THE ALLEGED FAILURE MODE IS NOT EXPECTED TO CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF A PATIENT. BASED ON THIS ADDITIONAL FAILURE ANALYSIS INVESTIGATION INFORMATION, THIS MDR REPORT IS BEING RETRACTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS NOTED TO HAVE A BROKEN TIP. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329434 LARGE CLIP APPLIER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420230-03 2009072 361

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES