BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8 MM MCS TIP COVER ACCESSORY

    MDR report key: 2823390 · Received November 7, 2012

    Report

    Report Number
    2955842-2012-00839
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DEFINITIVELY DETERMINED; HOWEVER, THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING EVALUATION FOUND THAT ONE GRIP CLOSE CABLE IS BROKEN AT THE DISTAL IDLERS. THE IDLER PULLEY SPINS FREELY AND WAS NOT DAMAGED. THE CABLE SEGMENT STICKS OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST ARE NOT DAMAGED. NO OTHER DAMAGE WAS FOUND. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE TIP COVER ACCESSORY IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: FOR THE CORRECT APPLICATION OF ELECTRO LUBE FOLLOW THE INSTRUCTIONS BELOW: ENSURE THAT THE TIP COVER ACCESSORY HAS BEEN PROPERLY INSTALLED ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT. DISPENSE A DROP OF ELECTRO LUBE ONTO THE FOAM PAD PROVIDED WITH THE ELECTRO LUBE SOLUTION. USING THE FOAM PAD, APPLY A THIN LAYER ONLY ONTO THE SCISSOR BLADES OF THE INSTRUMENT AS SHOWN IN FIGURE 2.7. WIPE OFF EXCESS ELECTRO LUBE LEAVING ONLY A THIN FILM ON THE SCISSOR BLADES. NOTE: DO NOT DIP THE INSTRUMENT INTO THE ELECTRO LUBE OR APPLY ELECTRO LUBE TO SURFACES OTHER THAN THE SCISSOR BLADES. AS OF (B)(6) 2012, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI MYOMECTOMY PROCEDURE THE MCS TIP COVER ACCESSORY INSTALLED ON THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT SLIPPED TOWARDS THE TIP OF THE INSTRUMENT. THE SITE ATTEMPTED TO REMOVE THE MCS INSTRUMENT WITH THE TIP COVER INSTALLED FROM THE PATIENT TO INSTALL A NEW TIP COVER ACCESSORY; HOWEVER, THE MCS INSTRUMENT BECAME STUCK, CAUSING DAMAGE TO THE MCS INSTRUMENT. THE CANNULA AND MCS INSTRUMENT WERE REMOVED SIMULTANEOUSLY TO ALLOW FOR REMOVAL OF THE INSTRUMENT FROM THE PATIENT. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THE ISSUE EXPERIENCED BY THE SITE WAS REPORTED TO ISI TECHNICAL SUPPORT ENGINEERING AFTER THE SITE HAD REMOVED THE MCS INSTRUMENT FROM THE PATIENT. DURING THE INVESTIGATION CONDUCTED BY THE TSE, THE TSE LEARNED THAT THE SITE APPLIED ELECTRO LUBE TO THE MCS INSTRUMENT PRIOR TO INSTALLATION OF THE TIP COVER ACCESSORY. THE TSE ADVISED THE CUSTOMER THAT THE APPLICATION OF ELECTRO LUBE ON TO THE BLADES OF THE MCS INSTRUMENT SHOULD BE PERFORMED AFTER THE MCS TIP COVER HAS BEEN INSTALLED ON TO THE MCS INSTRUMENT AND THAT ONLY A SMALL AMOUNT OF ELECTRO LUBE SHOULD BE APPLIED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH REPLACEMENT MCS INSTRUMENT AND TIP COVER ACCESSORY. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8 MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-12

    Patients

    Seq Age Sex Outcome Treatment
    1 DAV SI SURG SYS, MCS INSTRMNT, ACCESS & ESU