BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 15612483 · Received October 15, 2022

    Report

    Report Number
    2955842-2022-14611
    Event Type
    Injury
    Date Received
    October 15, 2022
    Date of Event
    September 14, 2022
    Report Date
    September 15, 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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OR ALLEGATION FROM THE CUSTOMER OF A DEFICIENCY OF THE DA VINCI SYSTEM, INSTRUMENTATION OR ACCESSORIES ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. A LOG REVIEW CONFIRMED THE PROCEDURE DATE OF 14-SEP-2022 ON SYSTEM SK3264. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO OPEN SURGERY AFTER THE START OF THE PROCEDURE, DUE TO AN ANATOMICAL CHALLENGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL PANCREATECTOMY SURGICAL PROCEDURE, THE PROCEDURE WAS CONVERTED TO OPEN AFTER THE START OF THE PROCEDURE DUE TO ANATOMICAL CHALLENGES. THE SURGEON STATED THAT CONTINUED DISSECTION WAS DIFFICULT, AND THERE WAS NO GOOD PLANE THAT COULD BE IDENTIFIED BETWEEN THE POSTERIOR ASPECT OF THE PANCREAS AND THE RETROPERITONEAL SPACE. BECAUSE THE SPLEEN AND TAIL OF THE PANCREAS WERE COMPLETELY MOBILIZED, THE SURGEON MADE THE DECISION TO PERFORM THIS TRANSECTION OF THE PANCREAS IN AN OPEN FASHION. THE PATIENT TOLERATED THE OPEN PROCEDURE WELL. THERE WAS NO PATIENT HARM/INJURY TO THE PATIENT. THE PROCEDURE HAD BEEN IN PROGRESS ABOUT 30 MINUTES WHEN THE ISSUE OCCURRED. THERE WERE NO POST-OPERATIVE COMPLICATIONS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO OPEN DUE TO AN ANATOMICAL CHALLENGE FOR THIS CASE. THE SURGEON NOTED THAT CONTINUED DISSECTION WAS DIFFICULT, AND NO GOOD PLANE COULD BE IDENTIFIED BETWEEN THE POSTERIOR ASPECT OF THE PANCREAS AND THE RETROPERITONEAL SPACE. BECAUSE THE SPLEEN AND TAIL OF THE PANCREAS WERE COMPLETELY MOBILIZED, THE SURGEON MADE THE DECISION TO PERFORM THIS TRANSECTION OF THE PANCREAS IN AN OPEN FASHION. THE SURGEON HAD NOT PLANNED TO CONVERT THE PROCEDURE. THE ROBOTICS COORDINATOR WHO PROVIDED THE INFORMATION WAS PRESENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2665847 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-41 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES