BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST SP

    MDR report key: 22116076 · Received May 30, 2025

    Report

    Report Number
    2955842-2025-23052
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    May 12, 2025
    Report Date
    February 18, 2026
    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
    AL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL FAILURE ANALYSIS (FA) WAS CONFIRMED, THE INSTRUMENT EXHIBITED A BROKEN MOLDED INSULATOR. THE INSTRUMENT WAS TRANSFERRED TO DESIGN ENGINEERING FOR FURTHER INVESTIGATION OF THE BROKEN MOLDED INSULATOR FAILURE MODE, AND THE GRIPS WERE DISASSEMBLED FROM THE INSTRUMENT FOR FURTHER INSPECTION. UPON DISASSEMBLY, IT WAS FOUND THAT THE GRIP WITH THE UNBROKEN MOLDED INSULATOR WAS BENT SLIGHTLY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: IMAGES OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. IMAGE REVIEW SHOWS A FENESTRATED BIPOLAR FORCEPS INSTRUMENT WITH A BROKEN MOLDED INSULATOR.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. 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 UPPER JAW. THE BROKEN PIECE MEASURES APPROXIMATELY 1.32MM X 9.38MM AND WAS NOT RETURNED WITH THE INSTRUMENT. THE GRIP BASE FOR THE GRIP WITH THE CRACKED MOLDED INSULATOR DOES NOT APPEAR TO BE BENT. ADDITIONAL FINDINGS NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE A DETACHED FRAGMENT. THE DETACHED FRAGMENT BROKE OFF FROM THE INSTRUMENTS MOLDED INSULATOR. THE DETACHED FRAGMENT WAS NOT RETURNED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT BROKE. THE OPERATING ROOM (OR) STAFF MEMBER CALLED THE TECHNICAL SERVICE ENGINEER (TSE) AND STATED PART OF THE PLASTIC COVERING THE TIP FELL INTO PATIENT AND THEY HAVEN'T BEEN ABLE TO LOCATE. IT IS UNKNOWN IF THE FRAGMENT WAS RETRIEVED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: A DEVICE FRAGMENT FELL INTO THE PATIENT WHILE DISSECTING. THE SURGEON WAS UNSURE OF THE CAUSE OF THE DETACHMENT, AND THE FRAGMENT WAS NOT RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURES WERE REQUIRED, AS INTUITIVE CONFIRMED THE FRAGMENT WAS RADIOLUCENT, MAKING X-RAYS INEFFECTIVE FOR DETECTION. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING A BACKUP FENESTRATED BIPOLAR INSTRUMENT. AT THE TIME OF REPORTING, NO PATIENT INJURY WAS OBSERVED, AND THE PATIENT HAD NOT YET RETURNED TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS RELATED TO A RETAINED FOREIGN OBJECT. THE BROKEN INSTRUMENT WAS THE FIRST FENESTRATED BIPOLAR USED. IT IS AVAILABLE FOR RETURN TO ISI FOR EVALUATION, BUT THE FRAGMENT WAS NOT RETRIEVED. PHOTOGRAPHIC IMAGES OF THE DEVICE ARE AVAILABLE FOR ISI REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13671 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-57 U10240124 0004 00886874114339

    Patients

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