BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 25263468 · Received May 23, 2026

    Report

    Report Number
    2955842-2026-26182
    Event Type
    Malfunction
    Date Received
    May 23, 2026
    Date of Event
    March 10, 2026
    Report Date
    May 22, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119785
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 8MM PROGRASP FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE GRIP AXIS PIN MISSING FROM THE GRIPS. THE PIN, MEASURING APPROXIMATELY 5.10 MM (LENGTH) X 1.85 MM (DIAMETER) WAS NOT RETURNED WITH THE INSTRUMENT. GRIPS AND OTHER COMPONENTS ADJACENT TO THE DISLODGED PIN DO NOT SHOW DAMAGE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO THE MANUFACTURING PROCESS. THIS PIN CAN BECOME DISLODGED AND STICKING OUT DUE TO IMPROPER SWAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM PROGRASP FORCEPS INSTRUMENT WAS DEFECTIVE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: INSTRUMENT WAS NO LONGER WORKING, EVEN THOUGH THERE WAS NO RED DOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551174 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-14 K13250327 0261 00886874119785

    Patients

    Seq Age Sex Outcome Treatment
    1