BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 14069024 · Received April 9, 2022

    Report

    Report Number
    2955842-2022-10985
    Event Type
    Malfunction
    Date Received
    April 9, 2022
    Date of Event
    March 10, 2022
    Report Date
    March 10, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K180351
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE FORCE BIPOLAR INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS TO BE PERFORMED, BUT THE INSTRUMENT HAS NOT YET BEEN RECEIVED. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG FOR THE FORCE BIPOLAR INSTRUMENT (471405-06 / K10211122-0057) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THE LOGS, THE INSTRUMENT WAS LAST USED ON 10-MARCH-2022. THIS COMPLAINT IS CONSIDERED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE FORCE BIPOLAR INSTRUMENT COULD NOT BE REMOVED FROM THE CANNULA DUE TO THE JAW DISLODGED. JAW DISLODGMENT COULD RESULT IN THE TIPS BEING STUCK AND UNABLE TO BE OPENED WITH MASTER TOOL MANIPULATOR (MTM) ACTIVATION OR INSTRUMENT RELEASE KIT (IRK) USE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR WHILE GRASPING TISSUE. MEDICAL INTERVENTION MAY BE REQUIRED IN THE EVENT THAT THE INSTRUMENT JAWS FAIL TO OPEN FROM TISSUE WHEN COMMANDED BY THE USER OR SYSTEM. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE GRIP/HINGE TO BECOME DISLODGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER WAS UNABLE TO REMOVE THE FORCE BIPOLAR INSTRUMENT. THE CUSTOMER STATED THEY HAD TRIED TO USE THE RELEASE KNOB WITHOUT SUCCESS. THE CUSTOMER WAS TRYING THE RELEASE KNOB AGAIN WHEN THEY CALLED TECH SUPPORT, AND THEY WERE ABLE TO SUCCESSFULLY REMOVE THE INSTRUMENT. THE CUSTOMER STATED THAT THE HINGE BROKE ON THE JAW. THE CUSTOMER STATED THAT THIS ISSUE HAS BEEN REOCCURRING OVER THE LAST THREE TIMES THEY PERFORMED THIS PROCEDURE. THE CUSTOMER CONTINUED WITH THE CASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROBOTICS COORDINATOR STATED THAT NO FRAGMENTS FELL INTO THE PATIENT, AS CONFIRMED BY VISUAL INSPECTION. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT. THE ROBOTICS COORDINATOR STATED THIS OCCURRED WHILE INSERTING MESH DOWN THE TROCAR. THE JAWS WERE STUCK ON THE MESH. THERE WAS NO ADVERSE EFFECT TO THE TISSUE, NO UNEXPECTED TISSUE REMOVAL, NO BLEEDING. THE ROBOTICS COORDINATOR INFORMED THAT THE FORCE BIPOLAR WAS BENT SO IT COULD NOT BE REMOVED AND WAS STUCK ON THE ARM. THE HINGE BROKE WHILE USING THE INSTRUMENT. THE ROBOTICS COORDINATOR STATED THE SURGEON RESOLVED THE ISSUE BY USING THE EMERGENCY KEY. THE ROBOTICS COORDINATOR BELIEVED THEY ALREADY RETURNED THE INSTRUMENT FOR EVALUATION, BUT THERE IS NO RMA CREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283500 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K10211122 0057 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES