BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 14868323 · Received June 30, 2022

    Report

    Report Number
    2955842-2022-12618
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    March 8, 2021
    Report Date
    March 18, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED COMPLICATION(S) CANNOT BE DETERMINED. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED IN RELATION TO THE REPORTED EVENT. THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. A REVIEW OF THE SYSTEM LOGS FOR THE EVENT DATE OF 08-MAR-2021 HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) POST MARKET SURVEILLANCE SPECIALIST AND THE FOLLOWING WAS OBSERVED: 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE, THE SURGEON NOTICED THAT UPON CLOSING THE ROBOTIC PORT SITES, THE PATIENT¿S SKIN WAS ¿ALMOST RUBBERY AND DRIED OUT; KIND OF PURPLE¿. NO OINTMENT WAS APPLIED AND NO MEDICAL INTERVENTION WAS REQUIRED. THE SURGEON CLOSED THE PORT SITES ¿AS USUAL¿. THE PROCEDURE COMPLETED WITH NO REPORTED INJURY AND THE PATIENT WAS REPORTED AS DOING WELL, POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE, THE SURGEON NOTICED THAT UPON CLOSING THE ROBOTIC PORT SITES, THE PATIENT¿S SKIN WAS ¿ALMOST RUBBERY AND DRIED OUT; KIND OF PURPLE¿. ON 25-MAR-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SURGEON, REGARDING THE REPORTED EVENT: AFTER THE SYSTEM WAS UNDOCKED FOR PORT SITE CLOSURES, THERE WERE NO BURN MARK(S) NOR DISCOLORING OF THE SKIN; THE PORTS CAME OUT FINE WITH NO DARK MARKS. HOWEVER, THE PATIENT¿S SKIN WAS ¿INITIALLY TIGHT AND WHITE, AS IF THERE WAS TOO MUCH PRESSURE ON THE TROCARS¿. THE SURGEON SAID THAT THIS WAS ¿A PRESSURE ISSUE, NOT AN INSULATION DEFECT, THERMAL DAMAGE, OR THERMAL INJURY¿. NO OINTMENT WAS APPLIED, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE SURGEON HAD CLOSED THE PORT SITES ¿AS USUAL¿, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE SURGEON ADDED THAT THERE WAS, ¿NO MALFUNCTION OF ANYTHING DA VINCI¿ AND THAT THE ISSUE WAS DIRECTLY RELATED TO ¿SURGICAL STAFF ERROR WITH PLACING THE TROCAR WRONG¿ BECAUSE, ¿THE STAFF SHOULD MAKE SURE THE THICK LINE ON THE TROCAR IS IN THE MIDDLE; BECAUSE, IF THE CENTER GETS MOVED A LITTLE OR IF THE CENTER LINE IS NOT IN THE RIGHT SPOT, IT PUTS MORE PRESSURE ON THE SKIN.¿ THE SURGEON ALSO SAID, ¿THIS IS NOT A TROCAR PROBLEM; RATHER IT WAS A USER PROBLEM¿. THE SURGEON DID NOT HAVE ACCESS TO PATIENT DEMOGRAPHIC DETAIL AND WAS UNABLE TO PROVIDE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137298 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

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