BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 18693804 · Received February 13, 2024

    Report

    Report Number
    2955842-2024-11235
    Event Type
    Injury
    Date Received
    February 13, 2024
    Date of Event
    January 15, 2024
    Report Date
    January 18, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND THE REPORTED FAILURE WAS NOT CONFIRMED. VISUAL INSPECTION DID NOT REVEAL ANY DAMAGE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY AND WERE ALIGNED. THE INSTRUMENT RELEASED ENERGY. THE INSTRUMENT WAS FULLY FUNCTIONAL AND NO PRODUCT ISSUE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PART; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA TAPP SURGICAL PROCEDURE, A FRAGMENT FROM THE FORCE BIPOLAR INSTRUMENT FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED, AND IT SEEMED LIKE IT WAS THE WIRE FROM THE WRIST OF THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED BEFORE USE AND NO DAMAGE OR ANYTHING OUT OF THE ORDINARY WAS NOTICED. THE SURGEON WAS USING THE SURGICAL INSTRUMENT TO GRASP ONTO TISSUE. THE SURGEON DOES NOT KNOW WHAT CAUSED THE BREAK. THE SURGEON HAD BEEN USING THE INSTRUMENT FOR HALF OF THE DURATION OF THE CASE WITH NO ISSUE. NO ISSUES WERE NOTICED UP UNTIL THE BREAK AND THE FRAGMENTED PART FELL INTO THE PATIENT. THE INSTRUMENT WAS ONLY USED TO GRASP THE ISSUE. THE SURGEON WAS REPOSITIONING THE GRASP ON THE ISSUE WHEN THEY NOTICED THE FRAGMENT FLYING OFF THE INSTRUMENT AND FALLING ONTO THE TISSUE IN THE ABDOMEN. THE INSTRUMENT WAS NOT REMOVED AFTER BEING INSERTED FOR ANY KIND OF EXCHANGE. AS THE INSTRUMENT WAS INITIALLY INSERTED INTO THE ABDOMEN, THERE WAS NO RESISTANCE. THE WRIST WAS STRAIGHTENED WHEN THE INSTRUMENT WAS REMOVED FROM THE ABDOMEN. NO RESISTANCE WAS NOTED AND NO DAMAGE TO THE CANNULA WAS NOTED. IT SEEMED AS IF THE WIRES WERE LOOSE AFTER THE FRAGMENT FELL INTO THE PATIENT. THE FRAGMENTS WERE RETRIEVED WITH A LAPAROSCOPIC INSTRUMENT. ALL THE FRAGMENTS WERE RETRIEVED. IT WAS VERIFIED VISUALLY BY THE SURGEON. NO ADDITIONAL SURGICAL PROCEDURE WAS NECESSARY TO RETRIEVE THE FRAGMENT. THE SURGEON WAS CERTAIN THEY OBTAINED THE FOREIGN OBJECT FROM THE PATIENT¿S ABDOMEN. THE PROCEDURE WAS CONTINUED ROBOTICALLY WITH ANOTHER INSTRUMENT. THERE WAS NO PATIENT INJURY. THE PATIENT HAS NOT RETURNED FOR ANY POST-OPERATIONS OR COMPLICATIONS. THE FRAGMENT WAS SENT DOWN TO STERILE PROCESSING AND TAPED TO THE INSTRUMENT. WHEN THE INSTRUMENT MADE IT BACK UP TO THE CUSTOMER, THE FRAGMENT WAS NO LONGER THERE AND COULD NOT BE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765840 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K11220905 0225

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES