BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 19667465 · Received July 3, 2024

    Report

    Report Number
    2955842-2024-16591
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    May 30, 2024
    Report Date
    June 7, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119815
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE GRIP HUB. THE BROKEN CABLE CAUSE NOT OPEN OR CLOSE PROPERLY. THE CABLE WAS FULLY BROKEN. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS STANDARD FOR THE TECH TO VISUALLY INSPECT THE INSTRUMENT WHEN RECEIVING IT ONTO THE STERILE FIELD. THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY. ACCORDING TO THE TECH, THE DRIVER MOVED SMOOTHLY, AND NO VISUAL DAMAGE WAS SEEN. THE CABLE WAS STILL ATTACHED TO THE INSTRUMENT INTERNALLY. IT WAS REMOVED WITH THE INSTRUMENT. ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURES WERE REQUIRED TO REMOVE ANY FRAGMENTS. THERE WERE NONE TO BE REMOVED. THERE WERE NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS AS THE FRAYED CABLE WAS ATTACHED TO THE INSTRUMENT. NO INJURIES WERE REPORTED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE PATIENT HAS ONLY RECEIVED A POST-OP OVER THE PHONE CALL CHECK BY THE NURSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE FOR A RIGHT INGUINAL HERNIA, THERE WAS A JERK TO THE MEGA-SUTURE CUT NEEDLE DRIVER INSTRUMENT, CAUSING THE DRIVER TO DROP THE NEEDLE. WHEN THE SURGEON WENT TO RETRIEVE THE NEEDLE, THEY NOTICED THAT THE JAWS OF THE DRIVER WERE NOT FUNCTIONING CORRECTLY AND THAT THERE WAS A CABLE FRAYED ON THE SECOND WRIST. IT WAS UNKNOWN IF THE FRAGMENT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED AS PLANNED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760481 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 0331 00886874119815

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES