BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 22813173 · Received August 15, 2025

    Report

    Report Number
    2955842-2025-34508
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    July 18, 2025
    Report Date
    November 26, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114339
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SINGLE PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM/REPRODUCE THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN MOLDED INSULATOR ON THE LOWER JAW. THE BROKEN PIECE MEASURE APPROXIMATELY 3.34MM X 5.91MM IN SIZE AND WAS NOT RETURNED WITH THE INSTRUMENT. AS A RESULT, A DISLODGED GRIP TIP WAS OBSERVED THAT WAS STILL ATTACHED TO THE INSTRUMENT. FA FOUND THE SECONDARY FAILURE OF DETACHED FRAGMENT TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. DUE TO THE BROKEN MOLDED INSULATOR, A DETACHED FRAGMENT WAS OBSERVED. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM APPLYING EXCESS FORCE ON THE INSTRUMENT TIP DURING HANDLING, INSERTION, USAGE (OVERLOADING), OR REMOVAL.

    Additional Manufacturer Narrative · 0

    CORRECTION TO H8 FIELD - UPDATED TO INITIAL USE OF DEVICE. THE INSTRUMENT WAS TRANSFERRED TO THE FAILURE ANALYSIS ENGINEER (FAE) TEAM FOR FURTHER INVESTIGATION: INITIAL FAILURE ANALYSIS WAS CONFIRMED; THE SINGLE PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT EXHIBITS A BROKEN MOLDED INSULATOR. THE ROOT CAUSE CAN BE ATTRIBUTED TO MISUSE AND/OR MISHANDLING. THE INSTRUMENT WAS TRANSFERRED TO DESIGN ENGINEERING FOR FURTHER INVESTIGATION OF THE BROKEN MOLDED INSULATOR FAILURE MODE AND THERE WERE NO ADDITIONAL FINDINGS. THE GRIP ASSOCIATED WITH THE UNBROKEN MOLDED INSULATOR WAS SUBJECTED TO LOAD TESTING TO GAIN INSIGHT ON THE POTENTIAL LOAD TYPE THAT COULD RESULT IN THE BENDING OBSERVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: TODAY, THE SURGEON REVIEWED THE VIDEO AND CONFIRMED THAT THERE WAS NO DETACHMENT INSIDE THE BODY. DURING THE PROCEDURE, THEY IMMEDIATELY NOTICED THE FORCEPS WERE BROKEN INSIDE THE BODY CAVITY AND CONFIRMED THERE WAS NO MATERIAL DEFECT WHEN REMOVING THEM. IT IS HIGHLY LIKELY THAT THE DEFECT OCCURRED DURING THE CLEANING AND STERILIZATION PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE, THE SINGLE PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD A BROKEN TIP. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    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
    2788180 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-57 U10240130 0002 00886874114339

    Patients

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