BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 20760610 · Received November 22, 2024

    Report

    Report Number
    2955842-2024-22198
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    October 22, 2024
    Report Date
    October 28, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE ANY PRODUCT THAT WAS USED DURING THIS REPORTED EVENT; THEREFORE, FAILURE ANALYSIS INVESTIGATIONS COULD NOT BE PERFORMED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED AND THE INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. A REVIEW OF THE PROVIDED IMAGES OF THE COMPLICATIONS WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL DEVELOPMENT ENGINEER (CDE). THE INJURIES TO THE PICTURED WRIST AND THUMB WERE CONFIRMED. THE CDE WAS UNABLE TO DIAGNOSE A ROOT CAUSE FOR THE INJURIES BASED ON THE COMPLAINT DETAILS AND THE IMAGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SACROCOLPOPEXY WITH HYSTERECTOMY PROCEDURE, THE PATIENT EXPERIENCED AN EXTERNAL SECOND-DEGREE BURN TO THE RIGHT THUMB AND LEFT FOREARM. DURING THE PROCEDURE, THE ERBE VIODV GENERATOR WAS USED, WITH SETTINGS OF DRY CUT E2 35W AND FORCED COAG E2 35W FOR MONOPOLAR; AND SOFT COAG E3 35W FOR BIPOLAR. THE GROUNDING PAD WAS PLACED ON THE RIGHT THIGH AND WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OR ANYTHING OUT OF THE ORDINARY OBSERVED. THERE WERE NO INTRAOPERATIVE COMPLICATIONS OR OBSERVATION OF ANY ARCING EVENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. ON POST-OPERATIVE DAY #5, THE PATIENT REPORTED A BLACK ROUND MARK ON THE RIGHT THUMB AND A ROUND BLISTER-LIKE MARK ON THE LEFT FOREARM NEAR THE WRIST. A PLASTIC SURGEON PROVIDED MEDICAL TREATMENT, AND RINDERON OINTMENT WAS APPLIED, AND THEN TREATMENT WAS CHANGED TO GOEBEN CREAM. ON POST-OPERATIVE DAY #16, THE PATIENT WAS ABLE TO END THE OUTPATIENT VISITS TO PLASTIC SURGERY SINCE THE BURN AREA HAD BECOME EPITHELIALIZED, THE SURGEON STATED THE CAUSE OF THE INJURY IS UNKNOWN, AS THE PATIENT¿S HANDS WERE PROTECTED DURING PROCEDURE WITH ANTI-SLIP AND FRICTION-REDUCING THIRD-PARTY CLOTH PRODUCTS. THE NURSE STATED THAT THE BURN COULD NOT HAVE OCCURRED EXTERNALLY, OTHERWISE THE SOFT CLOTH WOULD HAVE EXHIBITED SIGNS OF SCORCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797980 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-30 N/A 00886874110898

    Patients

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