BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 16447727 · Received February 27, 2023

    Report

    Report Number
    2955842-2023-10921
    Event Type
    Injury
    Date Received
    February 27, 2023
    Date of Event
    February 12, 2021
    Report Date
    January 30, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ALLEGED CAUSE OF THE INJURY TO THE ABDOMINAL AORTA WAS AN ACCIDENTAL LACERATION BY AN UNSPECIFIED TROCAR. SINCE THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION AND NO ADDITIONAL INFORMATION (PART NAME, MATERIAL NUMBER, LOT NUMBER, SERIAL NUMBER, ETC.) COULD BE OBTAINED FOR THE TROCAR, NO FURTHER EVALUATION COULD BE PERFORMED FOR THE DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. ALTHOUGH THE INITIAL DOCUMENTATION RECEIVED INDICATES THE USE OF AN INTUITIVE SURGICAL, INC (ISI) TROCAR, THIS INFORMATION COULD NOT BE VERIFIED VIA DEVICE LOGS, DUE TO INSUFFICIENT INFORMATION. IT IS UNKNOWN IF THE DA VINCI SYSTEM WAS DOCKED AT THE TIME OF THE EVENT, HOWEVER, NO RELATED SYSTEM ERRORS OCCURRED ON THE REPORTED PROCEDURE DATE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. DUE TO THE NATURE OF THE COMPLAINT (LITIGATION), ADDITIONAL INFORMATION REGARDING THE EVENT WAS NOT PROVIDED. THE INSTRUMENTS AND ACCESSORIES USER MANUAL FOR THE DA VINCI XI SYSTEM CONTAINS THE FOLLOWING CAUTIONS TO MINIMIZE THE RISKS ASSOCIATED WITH PORT PLACEMENT: APPROPRIATE PATIENT POSITIONING TO SHIFT ORGANS AWAY FROM THE PORT PLACEMENT SITE; AN ADEQUATE LEVEL OF INSUFFLATION; OBTURATOR TIP IS POINTING AWAY FROM MAJOR VESSELS, ORGANS, AND OTHER ANATOMIC STRUCTURES; WHEN POSSIBLE, VISUALIZATION OF THE ENTIRE INSERTION OF THE CANNULA USING THE ENDOSCOPE IS PREFERRED; AND UTILIZE CONTINUOUS, CONTROLLED PRESSURE WITH A DELIBERATE ROTATING MOTION WHEN PLACING THE CANNULA AND OBTURATOR. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AS PART OF A LEGAL DISPUTE, THE PLAINTIFF'S ATTORNEY CLAIMS THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY AND SALPINGO-OOPHORECTOMY PROCEDURE, A TROCAR REPORTEDLY PUNCTURED AND LACERATED THE PATIENT'S ABDOMINAL AORTA, "RESULTING IN MASSIVE HEMORRHAGING AND LIFE-THREATENING HARM." THE PROCEDURE WAS CONVERTED TO "OPEN LAPAROSCOPIC EXPLORATION," THE PATIENT WAS PLACED ON A VENTILATOR, AND A VASCULAR SURGEON INTERVENED. WHILE REPAIRING THE AORTA, THE PATIENT'S VENA CAVA WAS ALSO INJURED. AFTER VESSEL REPAIR, THE HYSTERECTOMY AND SALPINGO-OOPHORECTOMY PROCEDURE WAS DISCONTINUED.

    Description of Event or Problem · 0

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DAVINCI-ASSISTED HYSTERECTOMY AND SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2021. DURING THAT PROCEDURE, A TROCAR REPORTEDLY PUNCTURED AND LACERATED THE PATIENT'S ABDOMINAL AORTA, "RESULTING IN MASSIVE HEMORRHAGING AND LIFE-THREATENING HARM." THE PROCEDURE WAS CONVERTED TO "OPEN LAPAROSCOPIC EXPLORATION," THE PATIENT WAS PLACED ON A VENTILATOR, AND A VASCULAR SURGEON INTERVENED TO REPAIR A LACERATION TO THE PATIENT'S AORTA. WHILE REPAIRING THE AORTA, HER VENA CAVA WAS ALSO INJURED. AS A RESULT, THE PATIENT SUFFERED "MASSIVE PHYSICAL AND EMOTIONAL INJURY, PHYSICAL AND MENTAL PAIN AND SUFFERING, DISABILITY, [AND] IMPAIRMENT OF HER ABILITY TO LABOR AND ENJOY LIFE." THE PATIENT'S "INJURIES ARE BELIEVED TO BE PERMANENT IN NATURE." AFTER VESSEL REPAIR, THE HYSTERECTOMY AND SALPINGO-OOPHORECTOMY PROCEDURE WAS DISCONTINUED. THE TIMING AND CAUSE OF THE INJURIES TO THE ABDOMINAL AORTA AND TO THE VENA CAVA, THE SEVERITY OF THE BLEEDING, ANY FURTHER MEDICAL INTERVENTIONS, ANY FURTHER COMPLICATIONS, THE PATIENT'S CURRENT STATUS, AND/OR ADDITIONAL EVENT DETAILS, INCLUDING CONFIRMATION THAT THE DA VINCI SYSTEM WAS DOCKED AND THAT THE TROCAR IN QUESTION WAS AN INTUITIVE SURGICAL, INC DEVICE, ARE CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788345 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A

    Patients

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