BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 25074316 · Received May 4, 2026

    Report

    Report Number
    2955842-2026-23771
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 4, 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
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF THE DATE OF THIS REPORT, THE PROGRASP FORCEPS INSTRUMENT HAS NOT YET BEEN RECEIVED BY INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT YET BEEN DETERMINED.

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO IMPROPER CUSTOMER SETUP. BASED ON THE TECHNICAL SUPPORT ENGINEER (TSE) NOTES, THE SYSTEM ISSUE WAS LIKELY CAUSED BY EITHER AN IMPROPER STERILE ADAPTER (SA) CONNECTION OR THE INSTRUMENT CATCHING WHILE BEING REMOVED IN A BENT POSITION. IT CAN BE RESOLVED BY RESEATING THE SA AND POWER CYCLING THE SYSTEM, IF NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT ON ARM 1 COULD NOT BE REMOVED DUE TO THE JAWS BEING CAUGHT ON THE CANNULA. THE CUSTOMER REMOVED THE CANNULA WITH THE INSTRUMENT AS A RESULT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER EXPLAINED THAT THE LIKELY CAUSE WAS EITHER AN IMPROPER STERILE ADAPTER (SA) CONNECTION OR THE INSTRUMENT CATCHING WHILE BEING REMOVED IN A BENT POSITION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584683 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-15 K12250807 0135 00886874119785

    Patients

    Seq Age Sex Outcome Treatment
    1