BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 13910930 · Received March 25, 2022

    Report

    Report Number
    2955842-2022-10798
    Event Type
    Death
    Date Received
    March 25, 2022
    Date of Event
    February 18, 2022
    Report Date
    February 23, 2022
    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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED INTRA-OPERATIVE COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A MEDICAL REVIEW OF THE EVENT INFORMATION PROVIDED WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER AND THE FOLLOWING INFORMATION WAS PROVIDED: "THERE IS INSUFFICIENT INFORMATION IN THE DESCRIPTION OF EVENTS TO DETERMINE THE POTENTIAL CAUSE OF THE EVENT THAT CAUSED THE PATIENT TO BLEED THAT ULTIMATELY RESULTING IN THE PATIENT¿S DEATH DURING A PARTIAL NEPHRECTOMY PROCEDURE." A REVIEW OF THE SYSTEM LOGS FOR THE PROCEDURE DATE OF (B)(6) 2022 HAS BEEN PERFORMED BY AN ISI TECHNICAL SUPPORT ENGINEER (TSE) AND THE FOLLOWING WAS OBSERVED: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. MULTIPLE PROCEDURES HAVE BEEN PERFORMED ON THIS SYSTEM AFTER THIS REPORTED COMPLAINT WITH NO SERVICE REQUESTS BEING CREATED. AS A RESULT OF THIS REVIEW, THE TSE DID NOT RECOMMEND A FIELD SERVICE ENGINEER (FSE) VISIT THE SITE TO PERFORM SYSTEM VERIFICATION TESTING. A REVIEW OF THE INSTRUMENT LOGS FOR THE PROCEDURE DATE OF (B)(6) 2022 HAS BEEN PERFORMED AND THE FOLLOWING WAS OBSERVED: ALL MULTI-USE INSTRUMENTS USED IN THE CASE HAVE BEEN USED IN SUBSEQUENT PROCEDURES WITH THE EXCEPTION OF THE SINGLE-USE INSTRUMENTS AND THE FOLLOWING INSTRUMENTS: MARYLAND BIPOLAR FORCEPS (PART #470172-16, LOT #N10200330-0054. USES REMAINING: 3 ) AND PROGRASP FORCEPS (PART #471093-11, LOT #K12211206-0136, USES REMAINING: 17 ). BASED ON A SITE COMPLAINT HISTORY REVIEW, NONE OF THE INSTRUMENTS USED DURING THIS PROCEDURE HAVE A COMPLAINT LOGGED AGAINST THEM. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT EXPERIENCED UNCONTROLLED BLEEDING. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY TO CONTROL THE BLEEDING, BUT THE PATIENT ULTIMATELY EXPIRED. THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PARTIAL NEPHRECTOMY PROCEDURE THAT THE PATIENT EXPERIENCED BLEEDING. THE SOURCE AND CAUSE OF THE BLEEDING WAS NOT PROVIDED. THE SURGEON ATTEMPTED TO USE A LAPAROSCOPIC STAPLER TO STOP THE BLEEDING, BUT ENDED UP CONVERTING TO OPEN SURGERY. IT WAS REPORTED THAT THE INTERVENTION CONTINUED FOR TEN HOURS AFTER CONVERTING TO OPEN SURGERY TO CONTROL THE BLEEDING; HOWEVER, THE BLEEDING CONTINUED AND THE PATIENT ULTIMATELY PASSED AWAY. THE SURGEON OF THIS PROCEDURE WAS CONTACTED, BUT THE PHYSICIAN REFUSED TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885596 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

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