BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST SP

    MDR report key: 23372181 · Received October 23, 2025

    Report

    Report Number
    2955842-2025-42598
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    September 29, 2025
    Report Date
    November 24, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114339
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED, AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE IMAGE APPEARED TO SHOW A LOOSE GRIP TIP AND MOLDED INSULATOR FRAGMENTS FROM A SINGLE PORT (SP) FENESTRATED BIPOLAR FORCEPS INSTRUMENT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MOLDED INSULATOR ON THE LOWER JAW. THE BROKEN MOLDED INSULATOR LIKELY CAUSED THE GRIP TIP TO BE FULLY DETACHED. THE BROKEN PIECE WAS RETURNED WITH THE INSTRUMENT. THE GRIP BASE FOR THE GRIP WITH THE CRACKED MOLDED INSULATOR DOES NOT APPEAR TO BE BENT. VISUAL INSPECTION WAS PERFORMED AND FOUND NO EXTERNAL DAMAGE TO THE HOUSING OR MAIN TUBE. THE HOUSING WAS REMOVED FOR INSPECTION AND FOUND NO INTERNAL DAMAGES. THE INPUT DISKS WERE MANUALLY ARTICULATED WITH NO ISSUES. THE GRIP KNOB WAS ABLE TO ROTATE, ALLOWING THE GRIPS TO OPEN/CLOSE WITHOUT ANY ISSUES. ADDITIONAL FINDING(S) RELATED TO THE CUSTOMER REPORTED COMPLAINT: THE INSTRUMENT WAS FOUND TO HAVE A DETACHED FRAGMENT. FRAGMENTS WERE RETURNED AND WERE LIKELY CAUSED BY THE BROKEN OVER MOLDED INSULATOR. THE ENTIRE LOWER GRIP TIP WAS DETACHED. THE BIPOLAR INSTRUMENT'S CONDUCTOR WIRE WAS FOUND TO BE BROKEN. THE BROKEN WIRE WAS LIKELY CAUSED BY THE BROKEN OVER MOLDED INSULATOR. THE LOCATION OF THE WIRE IS ON THE SIDE WITH THE LOWER JAW. THE WIRE APPEARS STICKING OUT AND WOULD FAIL ELECTRICAL CONTINUITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE JAW OF THE FENESTRATED BIPOLAR FORCEPS WAS BROKEN. THREE FRAGMENTS WERE FOUND INSIDE THE ABDOMINAL CAVITY AND WERE RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE NURSE STATED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS NOTED. THE SURGICAL TASK BEING PERFORMED AT THE TIME OF THE DEVICE BREAKAGE AND FRAGMENT FALLING INSIDE OF THE PATIENT WAS DISSECTION. THE INSTRUMENT WAS IN USE FOR ABOUT 30 MINUTES; THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. IT WAS VISUALLY CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO RETRIEVE THE FRAGMENTS. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR A FRAGMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO A FOREIGN OBJECT. THE INSTRUMENT AND THE FRAGMENT WILL BE RETURNED TO ISI FOR FAILURE ANALYSIS. NO PATIENT¿ DEMOGRAPHIC INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506269 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-62 K11250327 0008 00886874114339

    Patients

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