BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 14837740 · Received June 27, 2022

    Report

    Report Number
    2955842-2022-12487
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    May 20, 2021
    Report Date
    May 20, 2021
    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
    NY, US
    Reporter Occupation
    003

    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 IN RELATION TO THE REPORTED EVENT. A SITE HISTORY REVIEW WAS CONDUCTED AND DID NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SYSTEM LOGS FOR THE EVENT DATE OF (B)(6) 2021 HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT 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 TO THE FOLLOWING CONCLUSION; THE PATIENT SUSTAINED INJURIES ON THE ABDOMINAL WALL AND BRUISING DURING A DA VINCI ASSISTED PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE COMPLETION A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, WHILE THE MONOPOLAR CURVED SCISSORS (MCS) ¿WITH TIPS UP¿, VESSEL SEALER EXTEND (VSE), AND MEGA NEEDLE DRIVER (MND) INSTRUMENTS WERE STILL DOCKED; THE OR TABLE STARTED TO MOVE SPONTANEOUSLY. THE OPERATING ROOM (OR) TABLE WAS IMMEDIATELY UNPLUGGED TO KEEP IT FROM MOVING; HOWEVER, THE UNINTENDED OR TABLE MOTION CAUSED UNSPECIFIED ¿SLIGHT BRUISING¿ AROUND TWO OF THE FOUR PORTS. THE HOSPITAL DID NOT USE TRUMPF BED AS THE SITE IS NOT EQUIPPED WITH ONE. THE SURGEON ASSESSED THE SITE WITH THE USE OF UNSPECIFIED LAPAROSCOPIC DIAGNOSTIC TOOL AFTER UNDOCKING THE DA VINCI SYSTEM, THERE WAS NO ADDITIONAL INJURY TO CRITICAL STRUCTURES OR DAMAGE TO SURROUNDING TISSUE NOTED. THE SURGEON CONFIRMED THAT THERE WAS NO MEDICAL INTERVENTION REQUIRED AND PORTS WERE NORMAL AND THE PATIENT WAS REPORTED TO BE STABLE. THE SURGEON DOES NOT BELIEVE THAT THE INTUITIVE DEVICE(S) CAUSED OR CONTRIBUTED TO THE REPORTED INJURY. THE SURGEON ATTRIBUTED THE CAUSE OF THE ISSUE TO THE SPONTANEOUS MOVEMENT OF AN OLD NON-ISI PRODUCT OR TABLE. THERE WAS NO ALLEGATION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY CAUSED OR CONTRIBUTED TO THE EVENT. PER REPORT, ALL DA VINCI PRODUCTS OPERATED AS EXPECTED THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749953 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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