BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24030313 · Received January 9, 2026

    Report

    Report Number
    2955842-2026-00792
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    December 21, 2025
    Report Date
    March 9, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP AT THE GRIP BASE. A PIECE APPROXIMATELY 15.00 MM X 4.71 MM WAS FOUND TO BE BROKEN OFF, CONFIRMING THAT A FRAGMENT DETACHED FROM THE INSTRUMENT. THE BROKEN PIECE WAS NOT RETURNED WITH THE INSTRUMENT. FURTHER INSPECTION FOUND NO ADDITIONAL DAMAGE OR ABNORMALITIES. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF A BROKEN GRIP TIP IS ATTRIBUTED TO USE CONDITIONS. DAMAGE TO THE INSTRUMENT CAN OCCUR WHILE PERFORMING ¿OFF-LABEL¿ SURGICAL APPLICATIONS, SUCH AS NEEDLE BENDING/DRIVING AND SUTURE SNAPPING, OR MISHANDLING THE INSTRUMENT. GRIP TIP FRAGMENTS MAY RESULT WHEN THE METAL INJECTION MOLDING (MIM) IS NOT RETAINED TO THE OVERMOLD (OM) DURING USE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE FORCE BIPOLAR INSTRUMENT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE. FIELD H10 IS BLANK AS THERE ARE NO RELATED REPORT NUMBERS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM FORCE BIPOLAR INSTRUMENT'S METAL INDUSTRY DETACHED ITSELF FROM THE PLASTIC SECTOR. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510273 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-09 K10250617 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1