BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 21664613 · Received March 21, 2025

    Report

    Report Number
    2955842-2025-09414
    Event Type
    Injury
    Date Received
    March 21, 2025
    Date of Event
    February 19, 2025
    Report Date
    February 20, 2025
    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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATIONS. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A FRAGMENT FROM THE SHAFT OF A MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT SHEARED OFF. THIS FRAGMENT PUNCTURED THE PATIENT'S ABDOMINAL WALL. IT IS UNKNOWN AT THIS TIME WHAT CAUSED THE BREAKAGE TO OCCUR OR THE EXTENT OF THE INJURY/REPAIR. THIS EVENT DELAYED THE PROCEDURE LESS THAN 15 MINUTES. THE FRAGMENT(S) WERE RETRIEVED DURING THE SAME PROCEDURE. THE FOLLOWING INFORMATION IS UNKNOWN: THE SEVERITY OF THE INJURY TO THE ABDOMINAL WALL AND WHAT MEDICAL INTERVENTION (IF ANY) WAS RENDERED DUE TO THE COMPLICATION. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901064 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 K11240808 0173 00886874119815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES