BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 16118708 · Received January 6, 2023

    Report

    Report Number
    2955842-2023-10011
    Event Type
    Death
    Date Received
    January 6, 2023
    Date of Event
    November 7, 2022
    Report Date
    December 8, 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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED 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 REVIEW OF THE INSTRUMENT LOGS FOR THIS PROCEDURE 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 INSTRUMENTS WITH NO MORE USES LEFT. A REVIEW OF THE SYSTEM LOGS FOR THIS PROCEDURE HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND THE FOLLOWING WAS OBSERVED: MULTIPLE PROCEDURES HAVE BEEN PERFORMED ON THIS SYSTEM AFTER THIS REPORTED COMPLAINT. NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE ON (B)(6) 2022 A MEDICAL REVIEW WAS PERFORMED BY AN ISI MEDICAL SAFETY OFFICER AND THE FOLLOWING INFORMATION WAS PROVIDED: "THE DUODENUM IS MOSTLY A RETROPERITONEAL STRUCTURE IN THE UPPER ABDOMEN AND THE SURGERY PERFORMED WAS PRIMARILY LOW IN THE PELVIS. THERE ARE MANY POSSIBLE CAUSES OF A DUODENAL PERFORATION. PORT PLACEMENT FOR A MIDLINE HIGH ABDOMINAL PORT IS ONE POSSIBILITY; EITHER DEVICES SUCH AS VERESS NEEDLE OR THE PORT ITSELF COULD HAVE BEEN FACTORS. ADDITIONALLY, PATIENT RELATED CAUSES INCLUDE ULCER DISEASE AND OTHER PREDISPOSING FACTORS. ADDITIONAL CAUSES OF PERFORATION AT THE TIME OF SURGERY BUT UNRELATED TO THE TECHNICAL ASPECTS OF THE OPERATION ITSELF WOULD INCLUDE UNINTENDED IATROGENIC PERFORATION FROM STANDARD EQUIPMENT SUCH AS A NASOGASTRIC PLACED TOO DEEPLY. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF AN ISI CAUSED OR CONTRIBUTED TO THE DUODENAL PERFORATION." THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE PATIENT EXPIRED FROM A HOLE IN THE DUODENUM. THE CAUSE OF THIS INJURY IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE PATIENT EXPIRED FROM A HOLE IN THE DUODENUM. THE SURGEON REPORTED THAT THEY WERE NOT AWARE OF THE HOLE DURING THE PROCEDURE, AND IT WAS FOUND POST-OPERATION. THE SURGEON REPORTEDLY HAS A RECORDING OF THIS PROCEDURE AND HAS VIEWED IT SEVERAL TIMES AND CANNOT DETERMINE THE CAUSE OF THE INJURY. THE SURGEON SAID NO INSTRUMENTS GO OUT OF VIEW OR WERE OBSERVED BEING INSTALLED IMPROPERLY AFTER VIEWING THE RECORDING OF THIS PROCEDURE. THE SURGEON SAID THE ENDOSCOPE PORT WAS PLACED AT THE LEFT UPPER QUADRANT AT PALMERS POINT. THE SURGEON REPORTED THAT THE DUODENAL PERFORATION WAS MIDLINE POSTERIOR AND NOT RETROPERITONEAL. THE INDICATION FOR THIS PROCEDURE WAS ENDOMETRIAL CANCER STAGING AND TREATMENT. THE SURGEON REPORTED THAT THERE WERE NO INTRA-OPERATIVE COMPLICATIONS DURING THE DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, NOR WERE THERE ANY CONCERNS DURING THE DA VINCI SURGERY. THE SURGEON REPORTED THAT NO SURGICAL TASKS WERE PERFORMED ON OR NEAR THE DUODENUM DURING THE DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE. THE SURGEON SAID THEY USED A PROGRASP FORCEPS INSTRUMENT, BIPOLAR ENERGY, SCISSORS, SUCTION, AND V-LOCK SUTURES WITH A NEEDLE DRIVER FOR THE HYSTERECTOMY. THERE WERE NO OTHER INJURIES FOUND BEYOND THE DUODENUM INJURY FOUND POST-OPERATION. A VERESS NEEDLE WAS NOT USED DURING THE DA VINCI PROCEDURE, AND THE PATIENT DID NOT HAVE A HISTORY OF ULCER DISEASE. THE PATIENT EXPERIENCED POST-OPERATIVE PAIN ON POST-OPERATIVE DAY (POD) #1 AND #2, AND WAS TREATED WITH PAIN MEDICATION. ON POD #3, THE PATIENT'S PAIN BECAME ¿SEVERE¿. THE PATIENT PRESENTED ON POD #3 ¿WITH ACUTE ABDOMEN TO A LOCAL ER.¿ THE PATIENT UNDERWENT SURGERY THAT SAME NIGHT AND A 1CM PERFORATION IN THE DUODENUM WAS FOUND. THE SURGEON REPORTED THERE WAS NO BLEEDING PRESENT WHEN THE DUODENUM INJURY WAS DISCOVERED ON POD #3. THE PATIENT REPORTEDLY RECEIVED THREE PROCEDURES IN TOTAL, AND RECEIVED BLOOD TRANSFUSIONS DURING THE THIRD PROCEDURE. THE SECOND AND THIRD PROCEDURES WERE PERFORMED OPEN TO WASH OUT THE PATIENT, IDENTIFY THE PROBLEM, AND ATTEMPT REPAIRING IT. THE PATIENT WAS REPORTEDLY HOSPITALIZED FOR MORE THAN A WEEK DUE TO THIS EVENT. THE SURGEON SAID THEY DO NOT KNOW THE CAUSE OF THE DUODENUM INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573732 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A 00886874110720

    Patients

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