BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 13480427 · Received February 8, 2022

    Report

    Report Number
    2955842-2022-10197
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    October 29, 2021
    Report Date
    January 12, 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
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSES OF THE REPORTED OPERATIVE COMPLICATIONS 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. THE FOLLOWING INVESTIGATIONS COULD NOT BE PERFORMED DUE TO INSUFFICIENT INFORMATION PROVIDED (I.E. EVENT DATE): SITE COMPLAINT HISTORY REVIEW, EVENT VERIFICATION, SYSTEM/INSTRUMENT LOG REVIEW. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE TITLED, ¿ROBOT-ASSISTED PANCREATODUODENECTOMY WITH THE DA VINCI XI: CAN THE COSTS OF ADVANCED TECHNOLOGY BE OFFSET BY CLINICAL ADVANTAGES? A CASE-MATCHED COST ANALYSIS VERSUS OPEN APPROACH,¿ IT IS NOTED THAT TEN PATIENTS UNDERWENT DA VINCI-ASSISTED PROCEDURES AND EXPERIENCED COMPLICATIONS: FOUR POST-OPERATIVE PANCREATIC FISTULAS, ONE BILE LEAK, 3 PATIENTS WHO EXPERIENCED ABDOMINAL COLLECTION, AND ONE PATIENT WHO WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR RECOVERY. THE CAUSES OF THE COMPLICATIONS ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE.

    Description of Event or Problem · 0

    ON 12-JAN-2022, INTUITIVE SURGICAL INC. (ISI) BECAME AWARE OF A JOURNAL OF SURGICAL ENDOSCOPY ARTICLE TITLED, ¿ROBOT-ASSISTED PANCREATODUODENECTOMY WITH THE DA VINCI XI: CAN THE COSTS OF ADVANCED TECHNOLOGY BE OFFSET BY CLINICAL ADVANTAGES? A CASE-MATCHED COST ANALYSIS VERSUS OPEN APPROACH¿ (DI FRANCO, G., LORENZONI, V., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED: ¿THE INCIDENCE OF POPF (POST-OPERATIVE PANCREATIC FISTULA) WAS SIMILAR BETWEEN THE TWO GROUPS: IT OCCURS IN 11/40 PATIENTS THE XI-RPD-GROUP (P = 0.527). NO DIFFERENCE WAS REPORTED ALSO IN TERMS OF POPF GRADING: IN OPD (OPEN PANCREATODUODENECTOMY) GROUP A BIOCHEMICAL LEAK WAS REGISTERED IN 7/40 PATIENTS (17.5%), A GRADE B POPF IN 3/40 PATIENTS (7.5%) AND A GRADE C POPF IN 1/40 PATIENT (2.5%), WHILE IN XI-RPD-GROUP A BIOCHEMICAL LEAK OCCURRED IN 3/20 PATIENTS (15%) AND A GRADE B POPF IN 1/20 PATIENT (5%) (P = 0.881). THE INCIDENCE OF CLINICALLY SIGNIFICANT POPF WAS 10% (4/40 PATIENTS) IN THE OPD-GROUP AND 5% (1/20 PATIENT) IN THE XI-RPD-GROUP, P = 0.501. GRADE B POPF REQUIRED A PERCUTANEOUS ABDOMINAL DRAINAGE PLACEMENT IN 1/3 PATIENT OF THE OPD-GROUP AND IN 1/1 PATIENT OF THE XI-RPD-GROUP. THE GRADE C POPF OF THE OPD-GROUP REQUIRED RE-OPERATION AND THE PATIENT EVENTUALLY DIED FOLLOWING THIS AND MULTIPLE OTHER COMPLICATIONS. ONLY IN THE XI-RPD-GROUP IT WAS REPORTED A BILE LEAK IN 1/20 PATIENT (5%) WHO WAS TREATED WITH THE POSITIONING OF AN ULTRASOUND-GUIDED BILIARY DRAINAGE (P = 0.154).¿ ADDITIONALLY, TABLE 6 WITHIN THE JOURNAL ARTICLE DOCUMENTS THAT THERE WAS A TOTAL OF TEN PATIENTS WHO EXPERIENCED COMPLICATIONS DURING OR AFTER THE DA VINCI PROCEDURE: FOUR POST-OPERATIVE PANCREATIC FISTULAS, ONE BILE LEAK, 3 PATIENTS WHO EXPERIENCED ABDOMINAL COLLECTION, AND ONE PATIENT WHO WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR RECOVERY. THE ARTICLE DOCUMENTS THAT THE DA VINCI PROCEDURES WERE ALL PERFORMED WITH A DA VINCI XI SYSTEM AND WITH THE FOLLOWING INSTRUMENTS: MONOPOLAR CURVED SCISSORS, MARYLAND BIPOLAR FORCEPS, AN UNSPECIFIED GRASPER INSTRUMENT, VESSEL SEALER EXTEND, AN UNSPECIFIED NEEDLE DRIVER INSTRUMENT, AND AN UNSPECIFIED CLIP APPLIER INSTRUMENT USING HEM-O-LOCK CLIPS. ON (B)(6) 2022, ISI CONTACTED ONE OF THE AUTHOR'S OF THIS ARTICLE WHO IS ALSO A SURGEON AND ADDITIONAL INFORMATION REGARDING THIS COMPLAINT WAS OBTAINED: THERE WERE NO MALFUNCTIONS OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY DURING ANY OF THESE PROCEDURES. THE OR STAFF INSPECTED THE SYSTEMS, INSTRUMENTS, AND ACCESSORIES PRIOR TO USE WITH NOTHING ABNORMAL NOTICED. THE PROCEDURES WERE ALL COMPLETED ROBOTICALLY AND THE POST-OPERATIVE COMPLICATIONS WERE REPORTED TO BE USUAL POST-OPERATIVE COMPLICATIONS. IT IS UNKNOWN WHAT INTERVENTION WAS PERFORMED TO ADDRESS THESE POST-OPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302858 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-44 N/A 00886874110720

    Patients

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