BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 3103641 · Received May 9, 2013

    Report

    Report Number
    2955842-2013-01585
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 11, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE BANANA PLUG WAS MISSING FROM THE BACK END. THE NUT THAT RETAINED THE PLUG WAS LOOSE IN THE CHASSIS. THE PLUG BECAME UNSCREWED. THE INSTRUMENT WAS BUILT IN 2006, PRIOR TO IMPLEMENTATION OF A LOCK WASHER AND LOCTITE TO HELP WITH RETENTION OF THE PLUG. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY (USING METAL CONTACT AT CONDUCTOR END) TESTING. ENGINEERING ALSO FOUND A DAMAGED CERAMIC SLEEVE AND PROXIMAL CLEVIS. THE ENTIRE CERAMIC SLEEVE WAS MISSING FROM THE YAW PULLEY. THE SLEEVE LIKELY BROKE IN MORE THAN ONE PIECE. THE PROXIMAL CLEVIS WAS CRACKED IN THE AXIAL DIRECTION HALFWAY BETWEEN THE EARS. THE CRACK ORIENTATION WAS CONSISTENT WITH OVERLOADING THE TIP WITH THE WRIST PITCHED. ENGINEERING CONCLUDED THAT BOTH FAILURES WERE LIKELY MISHANDLING RELATED. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS O HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. O DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203538 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-04 2306061 48

    Patients

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