BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 8855931 · Received August 2, 2019

    Report

    Report Number
    2955842-2019-10584
    Event Type
    Injury
    Date Received
    August 2, 2019
    Date of Event
    July 12, 2019
    Report Date
    July 17, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 08/06/2019, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE DA VINCI-ASSISTED RADICAL CYSTECTOMY PROCEDURE WAS RECORDED ON VIDEO. HOWEVER, THE VIDEO IS NOT AVAILABLE FOR ISI TO REVIEW. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE SURGEON AND/OR SITE DOES NOT BELIEVE THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE VESSEL INJURY SUSTAINED BY THE PATIENT. THE SITE ATTRIBUTED THE VESSEL INJURY TO THE TECHNIQUE OF THE SURGEON. THE SURGEON EXPLAINED THAT WHILE HE WAS ATTEMPTING TO GRASP VASCULAR TAPE THAT WAS PULLING THE EXTERNAL ILIAC ARTERY FOR DISSECTION WITH THE MARYLAND BIPOLAR FORCEPS INSTRUMENT, HE ¿ACCIDENTALLY STABBED IT.¿ BLOOD TRANSFUSIONS WERE ADMINISTERED AND THE VESSEL(S) WAS REPAIRED VIA LAPAROTOMY. AS OF (B)(6) 2019, THE PATIENT¿S STATUS WAS NOTED AS ¿STABLE.¿ BASED ON THE CURRENT INFORMATION PROVIDED, THIS EVENT IS NO LONGER DEEMED REPORTABLE DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY PROCEDURE, THE EXTERNAL ILIAC ARTERY WAS CUT AND THE PATIENT EXPERIENCED A BLOOD LOSS OF 3000 CC. HOWEVER, BASED ON FOLLOW-UP INFORMATION OBTAINED, THE SURGEON AND/OR SITE INDICATED THAT THEY DO NOT BELIEVE THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE VESSEL INJURY. ACCORDING TO THE SITE, THE VESSEL INJURY WAS ATTRIBUTED TO SURGICAL TECHNIQUE BY THE SURGEON. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED OR CAUSED/CONTRIBUTED TO THE INTRA-OPERATIVE COMPLICATION.

    Additional Manufacturer Narrative · 1

    ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2019. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY PROCEDURE, THE EXTERNAL ILIAC ARTERY WAS CUT AND THE PATIENT EXPERIENCED A BLOOD LOSS OF 3000 CC. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE PATIENT¿S INTRA-OPERATIVE COMPLICATION IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED OR CAUSED/CONTRIBUTED TO THE INTRA-OPERATIVE COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY PROCEDURE, THE EXTERNAL ILIAC ARTERY WAS CUT AND THE PATIENT EXPERIENCED A BLOOD LOSS OF 3000 CC. AS A RESULT, THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS ADMINISTERED DUE TO THE INTRA-OPERATIVE COMPLICATIONS. THE PATIENT WAS REPORTEDLY STABLE POST-OPERATIVELY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651390 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-41

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES| DA VINCI INSTRUMENTS AND ACCESSORIES