BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23240121 · Received October 7, 2025

    Report

    Report Number
    2955842-2025-40924
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 17, 2025
    Report Date
    October 29, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 8MM MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED WITH THE INSTRUMENT. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM APPLYING EXCESS FORCE ON THE INSTRUMENT SHAFTS AND/OR TIPS DURING HANDLING, INSERTION, USAGE (OVERLOADING), OR REMOVAL. THIS ISSUE CAN BE RESOLVED BY USING AN ALTERNATE INSTRUMENT TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 8MM MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT HAD A BROKEN TIP. THE NEEDLE HOLDER TIP HAS COMPLETELY BROKEN OFF. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING CENTRAL PROCESSING AND CLEANING, A VISUAL INSPECTION REVEALED THAT PART OF THE DISTAL TIP OF THE INSTRUMENT HAD BROKEN OFF; HOWEVER, THERE WERE NO REPORTS OR EVIDENCE OF FRAGMENTS FALLING INTO THE PATIENT, NO BROKEN CABLES AT THE INSTRUMENT WRIST, AND NO PHOTOGRAPHIC OR VIDEO DOCUMENTATION AVAILABLE FOR REVIEW. ADDITIONALLY, THERE HAVE BEEN NO REPORTS OF THE PATIENT RETURNING TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS RELATED TO RETAINED FOREIGN MATERIAL. ALL PATIENT DEMOGRAPHIC AND CLINICAL INFORMATION REQUIRED FOR FDA MEDICAL DEVICE REPORTING IS UNAVAILABLE FOR THIS EVENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1868527 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-17 K11250410 0409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES