BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 22679095 · Received July 31, 2025

    Report

    Report Number
    2955842-2025-31766
    Event Type
    Injury
    Date Received
    July 31, 2025
    Date of Event
    July 1, 2025
    Report Date
    July 1, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    ISIFA2024-09-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE FORCE BIPOLAR INSTRUMENT; HOWEVER, THE FAILURE ANALYSIS INVESTIGATION HAS NOT BEEN COMPLETED. ADDITIONAL PATIENT INFORMATION: BODY MASS INDEX (BMI): 23.88 KG/M2. HEIGHT: 5'5".

    Additional Manufacturer Narrative · 0

    THE FORCE BIPOLAR INSTRUMENT INVOLVED IN THIS COMPLAINT WAS RECEIVED AND TESTED BY FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP CABLE VISIBLE AT THE DISTAL END.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT HAD A BROKEN CABLE AND WAS REMOVED FROM THE PATIENT. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THERE WAS A DELAY GREATER THAN 30 MINUTES. ON (B)(6) 2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5172385 STATING: "DURING HYSTERECTOMY FACILITATED BY DAVINCI ROBOT EQUIPMENT, ROBOTIC INSTRUMENTS BECAME STUCK IN THE ROBOTIC ARM. PIECES OF THE ROBOTIC INSTRUMENT BROKE OFF WHILE INSIDE OF THE PATIENT. THE DAVINCI COMPANY HAD TO BE CALLED AND AN EMERGENCY STOP PROCEDURE WAS COMPLETED. ROBOTIC ARMS AND VISIBLE PIECES WERE REMOVED FROM THE PATIENT BY SURGEON. REF. REPORTS: MW5172384, MW5172386. PT CODE: 2687. DEVICE CODES: 1069, 4012." NOTE: ALTHOUGH THE MW THAT WAS RECEIVED REGARDING THIS EVENT REFERENCES THREE DIFFERENT MW REPORTS, AS OF THE DATE OF THIS REPORT, ONLY TWO HAVE BEEN RECEIVED (MW5172385 AND MW5172386) BY ISI. ALL THREE MW REPORTS WILL BE REFERENCED IN H10. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE PROCEDURE: A FORCE BIPOLAR INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS NOTED. THE INSTRUMENT WAS NOT REMOVED PRIOR TO THE BREAKAGE. THE CUSTOMER WAS TRYING TO REMOVE A FORCE BIPOLAR INSTRUMENT THROUGH THE CANNULA WHEN THEY FELT RESISTANCE AND THEN NOTICED PIECES HAD BROKEN OFF OF THE INSTRUMENT. THE CUSTOMER WAS UNABLE TO REMOVE THE INSTRUMENT FROM THE PATIENT. THE WRIST COULD NOT BE STRAIGHTENED BECAUSE THE WRIST OF THE INSTRUMENT WAS BROKEN OFF THE SHAFT, ABOVE THE WRIST OF THE INSTRUMENT. THE CUSTOMER HAD TO ADD A LAPAROSCOPIC PORT TO MAKE IT POSSIBLE TO GET THE INSTRUMENTS OUT. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT; THE AREA WAS VISUALLY INSPECTED AS COPIOUS AMOUNTS OF IRRIGATION WAS PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THERE WERE NO POST-OPERATIVE TESTS, SUCH AS AN X-RAY, TAKEN. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL FOR ANY KNOWN COMPLICATIONS. THE FRAGMENTS WERE NOT RETURNED WITH THE INSTRUMENT. THERE WERE NO IMAGES FOR REVIEW.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278093 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K12250206 0252 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.