BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST SP

    MDR report key: 22631911 · Received July 28, 2025

    Report

    Report Number
    2955842-2025-31451
    Event Type
    Injury
    Date Received
    July 28, 2025
    Date of Event
    July 6, 2025
    Report Date
    December 2, 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
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED IN THIS COMPLAINT HAS BEEN RECEIVED AND TESTED BY FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN MOLDED INSULATOR. BROKEN PIECES, MEASURING APPROXIMATELY 6.21 MM X 1.18 MM, 7.28 MM X 1.43 MM, AND 1.97 MM X 1.36 MM, WERE RETURNED WITH THE INSTRUMENT. ADDITIONAL OBSERVATIONS INCLUDE DETACHED FRAGMENTS DUE TO THE BROKEN MOLDED INSULATOR. THE INSTRUMENT ALSO HAD A DISLODGED GRIP TIP, MEASURING APPROXIMATELY 15.33 MM X 4.59 MM, WHICH WAS RETURNED WITH THE INSTRUMENT. THE INSTRUMENT WAS ALSO FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE DISTAL END, LOCATED AT THE MOLDED INSULATOR. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST, CONFIRMING A COMPLETE BREAK IN THE WIRE. NO THERMAL DAMAGE WAS FOUND ON THE INSTRUMENT. THE COMPONENTS ADJACENT TO THE BROKEN WIRE SHOW DAMAGE, WHICH MAY INDICATE POTENTIAL MISHANDLING OR MISUSE OF THE INSTRUMENT.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H2, H6, AND H11. ADDITIONAL INFORMATION: ADVANCED FAILURE ANALYSIS WAS PERFORMED AND THE INITIAL FAILURE ANALYSIS FINDINGS WERE CONFIRMED. THE INSTRUMENT EXHIBITED A BROKEN MOLDED INSULATOR ON ONE GRIP. THE INSTRUMENT WAS TRANSFERRED TO DESIGN ENGINEERING FOR FURTHER INVESTIGATION OF THE BROKEN MOLDED INSULATOR. THE SECOND GRIP DID NOT HAVE A BROKEN MOLDED INSULATOR BUT WAS FOUND TO BENT AFTER DISASSEMBLY.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, FOLLOWING DISSECTION OF THE UTERUS, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS USED FOR CERVIX VAULT SUTURING AND THE DARK GRAY RUBBER PART SECURING THE TIP AND SHAFT OF THE INSTRUMENT APPEARED SLIGHTLY LIFTED ON THE MONITOR. AFTER COMPLETING THE SUTURE, THE INSTRUMENT WAS INSPECTED AND FOUND TO BE IN GOOD CONDITION, SO IT WAS REATTACHED AND REUSED. SUBSEQUENTLY, WHILE MOVING THE SPECIMEN, THE TIP OF THE INSTRUMENT BROKE. THE INSTRUMENT WAS REMOVED, AND THE BROKEN TIP WAS LOCATED AND EXTRACTED FROM THE PATIENT'S ANATOMY DURING THE SAME PROCEDURE. THE SURGERY WAS COMPLETED USING THE SAME TYPE OF INSTRUMENT TO ACHIEVE HEMOSTASIS. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1652782 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-57 U10230913 0016 00886874114339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES