BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 21002015 · Received December 23, 2024

    Report

    Report Number
    2955842-2024-23396
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    November 18, 2024
    Report Date
    November 28, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE PERMANENT CAUTERY SPATULA (PCS) INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY SPATULA (PCS) INSTRUMENT AND PERFORMED FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE FAILED THE MECHANICAL ENGAGEMENT SEQUENCE. THE INSTRUMENT PITCH INPUTS FAILED TO ENGAGE WITH THE IN-HOUSE SYSTEM'S STERILE ADAPTER DURING MULTIPLE ATTEMPTS. A LOG REVIEW CONFIRMED ENGAGEMENT FAILURES. COMMON CAUSES OF ENGAGEMENT FAILURES ARE ATTRIBUTED TO AN OVER-CONSTRAINED DESIGN CONDITION BETWEEN THE MATING PARTS OF THE INSTRUMENT AND INSTRUMENT STERILE ADAPTER DISKS. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE INSTRUMENT WAS ALSO FOUND TO HAVE THE CABLE CRIMP FROM THE WRIST CONTROL CABLE AT THE GRIP HUB DISLODGED. AS A RESULT, THE CABLES APPEARED TO BE BROKEN BUT WERE NOT. THE CABLE CRIMP WAS CAPTURED INSIDE THE WELDED GRIP. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO A COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE PERMANENT CAUTERY SPATULA (PCH) HAD ENGAGEMENT ISSUES. THE PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE. HOWEVER, THE REASON AS TO WHY THE CASE WAS CONVERTED TO OPEN SURGERY IS UNKNOWN.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2626162 ENDOWRIST PERMANENT CAUTERY SPATULA NAY INTUITIVE SURGICAL, INC 470184-14 K10240425 0099

    Patients

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