BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24917976 · Received April 17, 2026

    Report

    Report Number
    2955842-2026-21845
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 27, 2026
    Report Date
    May 13, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112717
    PMA / PMN Number
    K152421
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 8MM CURVED-TIP STAPLER INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE LODGED STAPLES IN THE JAWS. THREE FULLY FORMED STAPLES WERE OBSERVED AT THE DISTAL END OF THE STAPLER WITHIN THE JAWS, PREVENTING THE RELOAD FROM ATTACHING TO THE INSTRUMENT. THE STAPLES WERE REMOVED, AND EIGHT WERE CONFIRMED. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO LOOSE STAPLES FROM FIRING ACROSS STAPLE LINES OR NOT HAVING A FULL BUNDLE OF TISSUE BETWEEN THE JAWS DURING USE. LOOSE STAPLES THAT DO NOT GO INTO TISSUE CAN BE DRAGGED INTO THE I-BEAM SLOT AS THE I-BEAM RETRACTS DURING UNCLAMPING. INCREASED DRIVE TRAIN FRICTION DURING CALIBRATION DUE TO A STAPLE LODGED IN THE PATH OF THE I-BEAM CAN PREVENT THE INSTRUMENT FROM REGISTERING THE RELOAD COLOR, WHICH THEN RESULTS IN AN INITIALIZATION FAILURE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WERE STAPLE REMNANTS LEFT IN THE TIP OF THE 8MM CURVED-TIP STAPLER INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING THE USE OF THE STAPLER, IT WAS NOTED THAT IT APPEARED TO HAVE HAD SOME STAPLE REMNANTS WHILE TRYING TO INSERT A NEW STAPLE LOAD. THE DEVICE WAS NOT USED, AND A NEW ONE WAS USED IN PLACE OF THAT STAPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548094 ENDOWRIST CURVED-TIP STAPLER 30 NAY INTUITIVE SURGICAL, INC 470530-09 T10250228 0013 00886874112717

    Patients

    Seq Age Sex Outcome Treatment
    1