BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST SP

    MDR report key: 22153455 · Received June 5, 2025

    Report

    Report Number
    2955842-2025-23483
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    May 16, 2025
    Report Date
    May 16, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114339
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MOLDED INSULATOR ON THE LOWER JAW. THE BROKEN PIECE MEASURED APPROXIMATELY 2.63MM X 8.06MM AND WAS NOT RETURNED WITH THE INSTRUMENT. THE GRIP BASE FOR THE GRIP WITH THE CRACKED MOLDED INSULATOR DID NOT APPEAR TO BE BENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ADDITIONAL INVESTIGATION FOUND TORSION ON THE GRIP BASE, THAT WAS ASSOCIATED WITH THE BROKEN MOLDED INSULATOR. THE GRIP BASE WAS INSPECTED AND WHEN VIEWED LOOKING AT THE GRIP TIP TOWARDS THE BASE, THE GRIP BASE ASSOCIATED WITH THE JAW WITH THE BROKEN MOLDED INSULATOR APPEARS TO EXHIBIT TORSION.

    Additional Manufacturer Narrative · 0

    ON 24-JUN-2025, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: "DURING A SINGLE PORT ROBOT PROSTATECTOMY, WE HAD AN INSTRUMENT BREAK WHILE INSIDE THE PATIENT. ALL PIECES OF THE FENESTRATED BIPOLAR INSTRUMENT WERE COLLECTED AND SENT TO SURGICAL SOLUTIONS. STAFF FROM SURGICAL SOLUTIONS WAS NOTIFIED. I ALSO CALLED THE INTUITIVE ROBOT REPRESENTATIVE, AND EMI." PATIENT DEMOGRAPHICS UPDATED PER DETAILS PROVIDED ON REGULATORY REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, HALF OF THE JAW OF THE FENESTRATED BIPOLAR FORCEPS FELL OFF INTO THE PATIENT AT THE START OF USE. A FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1631392 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-62 K11241212 0029 00886874114339

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES