BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 25344486 · Received May 31, 2026

    Report

    Report Number
    2955842-2026-26600
    Event Type
    Injury
    Date Received
    May 31, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 30, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119785
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE PROGRASP FORCEPS INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. THE SITE'S REPROCESSING DEPARTMENT REPORTEDLY DISCARDED THE INSTRUMENT. A REVIEW OF IMAGES PROVIDED THE CUSTOMER WAS PERFORMED. FROM THE SEVEN IMAGES PROVIDED, THE PROGRASP FORCEPS INSTRUMENT IS OBSERVED TO HAVE A BROKEN MAIN TUBE, WHICH LEAD TO A DISLODGED PROXIMAL CLEVIS AND A DISLODGED GRIP CABLE. FOUR PHOTOS SHOW A ROBOTIC NEEDLE DRIVER INSTRUMENT GRASPING A METALLIC FRAGMENT IN THE TIP OF THE JAWS, ALONG WITH ONE LOOSE FRAGMENT OF UNIDENTIFIABLE MATERIAL APPEARING JUST ABOVE THE NEEDLE DRIVER INSTRUMENT'S JAWS IN THE BACKGROUND OF THE IMAGE. BASED ON THE IMAGES, THE EXACT MATERIALS AND IF THEY ARE RETRIEVED IN FULL CANNOT BE DETERMINED. ANOTHER IMAGE SHOWS A COLLISION OF THREE INSTRUMENTS. THE IMAGE APPEARS TO SHOW A PROGRASP FORCEPS INSTRUMENT VISIBLY DAMAGED, A NEEDLE DRIVER INSTRUMENT, AND A MARYLAND BIPOLAR FORCEPS INSTRUMENT. THERE ARE AT LEAST TWO METALLIC FRAGMENTS IN THE SURGICAL SCENE AT THIS TIME. TWO OTHER PHOTOS SHOW JUST THE BROKEN PROGRASP FORCEPS INSTRUMENT WITH THE DISLOCATED CLEVIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE TIP OF THE PROGRASP FORCEPS INSTRUMENT BROKE OFF AND THE SHAFT PRACTICALLY CRUMBLED. THE FRAGMENTS THAT FELL INSIDE THE PATIENT WERE ALL REMOVED DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. THE SURGEON AND OR STAFF CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGERY WAS NEEDED DUE TO THE EVENT. ALSO, NO POST-OPERATIVE TESTS WERE CONDUCTED TO VERIFY ALL FRAGMENTS WERE RETRIEVED. THE SITE'S REPROCESSING DEPARTMENT DISPOSED OF THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371520 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-15 K10250821 0296 00886874119785

    Patients

    Seq Age Sex Outcome Treatment
    1