BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 14710507 · Received June 16, 2022

    Report

    Report Number
    2955842-2022-12186
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    April 27, 2021
    Report Date
    May 3, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    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. BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE REPORTED POSTOPERATIVE COMPLICATION REMAINS UNKNOWN; HOWEVER, IT WAS INDICATED THAT IS WAS LIKELY RELATED TO THE PATIENT¿S UNSPECIFIED PRE-EXISTING MEDICAL CONDITION. A SYSTEM LOG REVIEW WAS PERFORMED AND THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE AND THE LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE THE PATIENT EXPERIENCED GASTROINTESTINAL PAIN AND WAS LATER IDENTIFIED TO HAVE A BILE LEAK, WHICH REQUIRED UNSPECIFIED NON-SURGICAL INTERVENTION TO RESOLVE. THE CAUSE OF THE POST-OPERATIVE COMPLICATION IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS. THE INITIAL PROCEDURE HAD COMPLETED WITHOUT INCIDENT. THE SURGEON USED FIREFLY ICG DURING THE CASE AND THERE WERE NO KNOWN ISSUES UPON PROCEDURE COMPLETION. HOWEVER, THE PATIENT HAD GASTROINTESTINAL (GI) PAIN AND A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED AT A DIFFERENT HOSPITAL BUT ¿EVERYTHING CAME BACK NORMAL.¿ THE HOSPITAL RECOMMENDED THAT THE PATIENT GO TO THE HOSPITAL WHERE THE INITIAL SURGERY WAS PERFORMED, IT WAS DETERMINED THE PATIENT HAD A SMALL BOWEL LEAK. THE SURGEON DOES NOT BELIEVE THE EVENT IS RELATED TO AN ISI PRODUCT; THE SURGEON BELIEVED THERE WAS A BILE LEAK INTO THE DUCT OF THE LUSCHKA. ON 04-MAY-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT DID WELL IMMEDIATELY POST-OPERATIVELY. ON APPROXIMATELY POST-OP DAY THREE, THE PATIENT EXPERIENCED STOMACH PAIN AND WENT TO ANOTHER HOSPITAL WHERE A CT SCAN WAS PERFORMED WITH NO CONCLUSIVE CAUSE FOR THE STOMACH PAIN. THE HOSPITAL CONTACTED THE SURGEON OF RECORD AND THE SURGEON REQUESTED TO EXAMINE THE PATIENT, WHICH IS WHEN THE SMALL BILE LEAK WAS IDENTIFIED. THE SURGEON SAID THAT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WAS USED AND THAT ¿ROUTINE TREATMENT THAT IS NON-SURGICAL IN NATURE¿ IS BEING ADMINISTERED AND THE PATIENT IS DOING WELL. THE SURGEON ATTRIBUTED THE CAUSE OF THE BILE LEAK INTO THE DUCT OF THE LUSCHKA, TO THE PATIENT¿S UNDISCLOSED ¿PRE-EXITING MEDICAL CONDITION¿ AND ¿BAD LUCK.¿ ALL INSTRUMENTS AND THE SYSTEM FUNCTIONED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255651 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-39 N/A 00886874115404

    Patients

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