BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 20510458 · Received October 22, 2024

    Report

    Report Number
    2955842-2024-20852
    Event Type
    Injury
    Date Received
    October 22, 2024
    Date of Event
    September 25, 2024
    Report Date
    September 25, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112311
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PERMANENT CAUTERY HOOK HAD A BROKEN PROXIMAL CLEVIS AT BOTH SIDE OF THE EARS OF THE CLEVIS. THE BROKEN PIECES WERE NOT RETURNED. CLEVIS DOES NOT SHOW ABRASIONS OR SCRATCHES ON THE OUTER SURFACE. COMPONENTS ADJACENT TO THE BROKEN CLEVIS DO NOT SHOW DAMAGE. .

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE PERMANENT CAUTERY HOOK INSTRUMENT WAS NOTED TO BE BROKEN. THE BLACK PLASTIC PIECE OF JOINT WAS NOT PRESENT. PER SURGEON, THE PIECE WAS NOT NOTED TO HAVE FALLEN OFF INSIDE THE PATIENT. THE PATIENT'S ANATOMY WAS THOROUGHLY SEARCHED WITHOUT FINDING ANY FOREIGN BODY. THE PROCEDURE WAS COMPLETED. THE CUSTOMER ALSO CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) PREVIOUSLY DURING THE SAME PROCEDURE AND REPORTED THAT A CAUTERY HOOK INSTRUMENT BROKE INSIDE THE PATIENT. PRIOR TO CONTACTING THE TSE, THE CUSTOMER USED THE INSTRUMENT RELEASE KIT (IRK) TOOL TO REMOVE THE INSTRUMENT. CUSTOMER USED A BACKUP INSTRUMENT AND CONTINUED AS PLANNED. CALLER STATED THE PROXIMAL CLEVIS BLACK SILICONE AREA OF THE INSTRUMENT BROKE APART AND THEY WERE UNSURE IF ANY FRAGMENTS FELL INTO THE PATIENT. TSE INFORMED CALLER THAT THE BLACK SILICONE OF THE PROXIMAL CLEVIS WAS NOT X-RAY DETECTABLE. THERE WAS NO REPORTED INJURY. PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) ALSO RECEIVED USER FACILITY REPORT (B)(4) STATING: DURING A PARTIAL LIVER RESECTION ON THE ROBOT, ONE OF THE ROBOTIC INSTRUMENTS WAS NOTED TO BE MISSING/BROKEN. THE INSTRUMENT WAS ATTEMPTED TO BE REMOVED BUT COULD NOT BE PULLED OUT OF THE TROCAR. AN EMERGENCY RELEASE KEY WAS USED TO ASSIST IN REMOVING THE INSTRUMENT. NO PATIENT INJURY HAPPENED DURING THIS INCIDENT. THE INSTRUMENT WAS EXAMINED, AND A PIECE OF DARK PLASTIC WAS NOTED TO BE MISSING FROM THIS INSTRUMENT. SURGEON AND THE TEAM EXAMINED THE AREA INSIDE THE PATIENT AND NO FOREIGN BODY WAS NOTED. SURGEON STATED HE WILL BE DOING A FULL SWEEP OF THE PATIENT'S ABDOMEN TO VERIFY NO FOREIGN BODY FROM THIS INSTRUMENT. DVI STAT WAS CALLED TO VERIFY IF THE PIECE COULD BE DETECTED BY X-RAY, BUT THIS PLASTIC PIECE IS NOT DETECTABLE. ISI FOLLOWED UP WITH THE CUSTOMER AND OBTAINED ADDITIONAL INFORMATION. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AS CURSORY INSPECTION. NOTHING OUT OF THE ORDINARY WAS NOTED. THE LOT NUMBER OF THE FAULTY CAUTERY HOOK INSTRUMENT WAS K14230928 0098. IT WAS NOTED THAT IT WAS DEFINITIVE THAT A FRAGMENT FELL INSIDE THE PATIENT'S ANATOMY. THE INSTRUMENT WAS IDENTIFIED TO BE BROKEN DURING REMOVAL OF THE INSTRUMENT. THE SURGEON BELIEVES THE INSTRUMENT WAS BROKEN BEFORE USE. THE INSTRUMENT WAS IN USE FOR LESS THAN 5 MINUTES PRIOR TO THE ISSUE AND HAD FUNCTIONED PROPERLY. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE. THE SURGICAL STAFF FELT RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA DURING REMOVAL. THE INSTRUMENT WOULD NOT COME THROUGH REDUCER. UPON FINAL REMOVAL, THE SURGICAL STAFF FELT RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE WRIST WAS STRAIGHTENED. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED AND THE SURGICAL STAFF DID NOT NOTICE ANY OTHER DAMAGE TO THE INSTRUMENT AFTER THE EVENT OCCURRED. NO FRAGMENTS WERE RETRIEVED. NO FRAGMENTS REMOVED, NO FRAGMENTS FOUND, MISSING PLASTIC PIECE NOTED ON INSTRUMENT. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS AS THE MATERIAL WOULD NOT BE DETECTABLE ON THE X-RAY. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE RISK MANAGEMENT TEAM WILL DETERMINE IF THE INSTRUMENT CAN BE RETURNED TO ISI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38326 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-16 K14230928 0098 00886874112311

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES