BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 23164275 · Received September 29, 2025

    Report

    Report Number
    2955842-2025-39812
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    September 4, 2025
    Report Date
    October 28, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE SINGLE PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT; HOWEVER, INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT YET BEEN DETERMINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. CONTACTED ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CSR DOES NOT KNOW IF THE CUSTOMER TRIED TO USE THE INSTRUMENT AGAIN ON THE (B)(6) 2025 ON RELATED PATIENT IDENTIFIER (B)(6), BUT SHE SAID THE INSTRUMENT WAS OBVIOUSLY BROKEN AND THE CUSTOMER KNEW IT HAD TO BE RETURNED BACK TO ISI. THE SINGLE PORT FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAS BEEN EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA WAS ABLE TO CONFIRM/REPRODUCE THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN MOLDED INSULATOR ON THE UPPER JAW. THE BROKEN MOLDED INSULATOR LIKELY CAUSED THE GRIP TIP TO BE FULLY DETACHED. THE BROKEN PIECE MEASURES APPROXIMATELY 15.31MM X 4.16MM AND WAS NOT 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 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. 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 FINDING(S) RELATED TO THE CUSTOMER REPORTED COMPLAINT: THE INSTRUMENT WAS FOUND TO HAVE A DETACHED FRAGMENT. THE FRAGMENT WAS NOT RETURNED AND WAS LIKELY CAUSED BY THE BROKEN OVER MOLDED INSULATOR. THE ENTIRE UPPER GRIP TIP WAS DETACHED. THE ROOT CAUSE IS TYPICALLY ATTRIBUTED TO USE CONDITIONS. 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 UPPER JAW. THE WIRE APPEARS STICKING OUT AND WOULD FAIL ELECTRICAL CONTINUITY. THE ROOT CAUSE IS TYPICALLY ATTRIBUTED TO USE CONDITIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED MASTECTOMY SURGICAL PROCEDURE, AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTED THAT SURGEON WANTED A BEDSIDE ASSISTANT TO TAKE OUT THE INSTRUMENTS TO CLEAN. WHEN THE BEDSIDE TRIED TO CLEAN THE SINGLE PORT FENESTRATED BIPOLAR FORCEPS (FBF), ONE OF THE TIPS BROKE AND WAS DANGLING. THERE WAS NO EXCESSIVE FORCE ON THE TIPS TO CLEAN, AND BEFORE IT WAS REMOVED FROM THE SYSTEM, THE SURGEON FOUND IT STRANGE THAT THE BIPOLAR ENERGY DID NOT SEEM TO WORK. SPARE INSTRUMENT WAS USED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON FIRST OBSERVED THAT THE FENESTRATED BIPOLAR FORCEPS WAS NOT DELIVERING ENERGY CONTINUOUSLY. IT WAS INTERMITTENT ENERGY DELIVERY. THE SURGEON ASKED BEDSIDE ASSISTANT TO CLEAN THE INSTRUMENT TIP. WHEN THE INSTRUMENT WAS TAKEN OUT OF PATIENT, UPON VISUAL INSPECTION, NO DAMAGE WAS NOTED. WHILE CLEANING THE TIP, ONE OF THE TIP PARTS BROKE OFF AND COMPLETELY DETACH FROM THE INSTRUMENT. THE EVENT OCCURRED OUTSIDE ON PATIENT. NO FRAGMENT FELL INTO PATIENT. THE PROCEDURE WAS CONTINUED USING BACK UP INSTRUMENT. PATIENT DEMOGRAPHIC WAS NOT PROVIDED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218778 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-57 U10221013 0030

    Patients

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