BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 17912779 · Received October 11, 2023

    Report

    Report Number
    2955842-2023-19095
    Event Type
    Death
    Date Received
    October 11, 2023
    Date of Event
    August 31, 2023
    Report Date
    September 11, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INJURY LEADING TO THE PATIENT'S DEATH IS NOT ABLE TO BE DETERMINED. NO INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS BEEN IMPLICATED OR RETURNED FOR FAILURE ANALYSIS. THE ROBOTICS COORDINATOR (ROCO) CONFIRMED THE LAPAROSCOPIC STAPLER AND THE BULLDOG CLAMPS AND THEIR APPLICATOR USED DURING THE PROCEDURAL COMPLICATIONS WERE THIRD-PARTY PRODUCTS. THE MANUFACTURER(S) OF THE LAPAROSCOPIC STAPLER AND BULLDOG CLAMPS WAS REQUESTED BUT WAS NOT PROVIDED. LOGS CONFIRM AN ISI STAPLER WAS NOT USED DURING THE PROCEDURE. A SYSTEM LOG REVIEW DID NOT REVEAL ANY SYSTEM ERRORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT PROCEDURE. REVIEW OF 23 SUBSEQUENT PROCEDURES PERFORMED WITH THE DA VINCI SYSTEM AFTER THIS EVENT FOUND NO REPORTED COMPLAINTS HAVE BEEN RECEIVED. A DEVICE HISTORY RECORD REVIEW FOR THE DEVICE(S) USED DURING THE PROCEDURE SHOWED NO NON-CONFORMANCES RELATED THIS EVENT WERE IDENTIFIED. A SITE HISTORY REVIEW FOUND THAT THE FOLLOWING INSTRUMENTS FROM THIS PROCEDURE HAVE SUBSEQUENTLY BEEN USED WITH NO REPORTED COMPLAINTS: 8MM 30 DEGREE ENDOSCOPE, MONOPOLAR CURVED SCISSORS, FENESTRATED BIPOLAR FORCEPS, AND PROGRASP FORCEPS. ADDITIONALLY, A SECOND MONOPOLAR CURVED SCISSORS AND A LARGE NEEDLE DRIVER HAD ZERO LIVES REMAINING AFTER THIS PROCEDURE AND THEREFORE WERE NOT USED IN SUBSEQUENT PROCEDURES AND PRESUMED TO HAVE BEEN DISCARDED. LASTLY, A SECOND LARGE NEEDLE DRIVER AND A MARYLAND BIPOLAR FORCEPS HAD LIVES REMAINING; HOWEVER, THE DEVICES WERE NOT USED AFTER THE REPORTED PROCEDURE. THERE WERE NO REPORTED ISSUES ANY OF THESE DAVINCI INSTRUMENTS. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THE PATIENT IN THIS REPORT WAS UNDERGOING A PARTIAL NEPHRECTOMY WHEN BLEEDING OCCURRED DESPITE THE PLACEMENT OF BULLDOG CLAMPS. THE SEVERITY OF THE BLEEDING AT THAT POINT IN THE OPERATION IS UNKNOWN. A 3RD PARTY STAPLER WAS USED IN AN ATTEMPT TO CONTROL THE RENAL ARTERY BLEEDING BUT THE STAPLER FAILED CAUSING MORE BLEEDING. THE DETAILS OF HOW THAT FAILURE OCCURRED ARE UNKNOWN. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY BUT THE PATIENT CONTINUED TO BLEED AND EXPIRED DURING THE PROCEDURE. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PARTIAL NEPHRECTOMY, THE PATIENT EXPIRED. THE VICE PRESIDENT OF SURGICAL SERVICES INFORMED INTUITIVE SURGICAL, INC. (ISI) THAT THE RENAL ARTERY WAS DISSECTED AND DESPITE HAVING TWO BULLDOG CLAMPS ON IT, THERE WAS PERSISTENT BLEEDING. THE DECISION WAS MADE TO PERFORM A TOTAL NEPHRECTOMY IN AN ATTEMPT TO STOP THE BLEEDING. HOWEVER, THERE WAS A MISFIRE WHEN STAPLING THE RENAL ARTERY WITH A THIRD-PARTY LAPAROSCOPIC STAPLER. THE PROCEDURE WAS CONVERTED TO OPEN, BUT THE MISFIRE CAUSED A SIGNIFICANT AMOUNT OF BLEEDING THAT THE PATIENT DID NOT SURVIVE. THERE WAS NO REPORTED MALFUNCTION OF ANY INTUITIVE SURGICAL, INC. (ISI) PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067643 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-22 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES