BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 23033578 · Received September 11, 2025

    Report

    Report Number
    2955842-2025-36810
    Event Type
    Injury
    Date Received
    September 11, 2025
    Date of Event
    June 2, 2025
    Report Date
    August 25, 2025
    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
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROGRASP FORCEPS INSTRUMENT IS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: THE CASE WAS SCHEDULED AS A DAVINCI XI LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH MESH. DURING THE CASE THE GRASPING MECHANISM ON THE PROGRASP FORCEP STOPPED WORKING. IT WAS TAKEN OUT OF THE SURGICAL SITE AND LOOKED AT ON THE FIELD. A PIN FELL OUT OF THE PROGRASP FORCEP. THE DEVICE WAS LOOKED AT BY THE INSTRUMENT ROOM STAFF AND THOUGHT TO BE INTACT. AN X-RAY WAS TAKEN OF T HE SURGICAL SITE. X-RAY WAS CLEAR OF FOREIGN RETAINED OBJECT. IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA TAPP PROCEDURE THE PROGRASP FORCEPS INSTRUMENT BROKE WHILE SECURING THE MESH CIRCUMFERENTIALLY WITH RUNNING VICRYL SUTURES. THE SITES RISK MANAGER STATED, THE SURGEON'S INSIGHT INTO WHAT CAUSED THE FRAGMENT TO DETACH IS NOT AVAILABLE. ACCORDING TO THE MEDICAL RECORD, THE INSTRUMENT WAS REMOVED FROM THE ABDOMEN INTACT, WHICH IMPLIES THAT NO FRAGMENTS WERE LEFT INSIDE. THE MEDICAL RECORD INDICATES THAT NO ADDITIONAL SURGICAL PROCEDURE WAS NECESSARY TO REMOVE THE FRAGMENT. TO ENSURE NO PIECES OF THE INSTRUMENT REMAINED, A POST-OPERATIVE X-RAY WAS PERFORMED, CONFIRMING NO LEFTOVER FRAGMENTS IN THE ABDOMEN. THERE WAS NO INJURY TO THE PATIENT, AS CONFIRMED BY THE MEDICAL RECORD, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL WITH ANY COMPLICATIONS RELATED TO RETAINED FOREIGN OBJECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2304674 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-11 K12240919 0043 00886874119785

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Unknown Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.