BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST SP

    MDR report key: 20563992 · Received October 29, 2024

    Report

    Report Number
    2955842-2024-21079
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    September 30, 2024
    Report Date
    September 30, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114322
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER FAILURE ANALYSIS INVESTIGATION CONFIRMED INITIAL FINDINGS. THE INSTRUMENT WAS REQUESTED TO BE TRANSFERRED FOR DESIGN ENGINEERING TO REVIEW IN PERSON DUE TO THE BROKEN MOLDED INSULATOR. NO ADDITIONAL FINDINGS WERE OBSERVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS TESTING. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MOLDED INSULATOR. A BROKEN PIECE, MEASURING APPROXIMATELY 1.25MM X 7.90MM IN SIZE, WAS RETURNED WITH THE INSTRUMENT. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. ADDITIONAL OBSERVATIONS NOT REPORTED BY THE SITE WERE ALSO IDENTIFIED. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED GRIP TIP. THE DISLODGED GRIP TIP, MEASURING APPROXIMATELY 4.16MM X 12.46MM, WAS RETURNED WITH THE INSTRUMENT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE DISTAL END. THE BREAK ON THE CONDUCTOR WIRE IS 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. A BROKEN MOLDED INSULATOR AND DISLODGED GRIP TIP WERE OBSERVED.

    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 SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS NOT GRIPPING AND THERE WAS NO SURROUNDING TISSUE TO GET CAUGHT ON. THE TIP WAS NOT VISIBLE ON THE CAMERA AT THE MOMENT OF REMOVAL. NOTHING UNUSUAL WAS NOTICED WHEN IT WAS REMOVED. AFTER THE PROCEDURE WAS COMPLETED AND THE ABDOMINAL CAVITY WAS CHECKED WITH THE CAMERA, A FOREIGN OBJECT WAS FOUND INSIDE THE PATIENT'S ANATOMY. UPON CLOSER INSPECTION IT WAS REALIZED TO BE A BROKEN PIECE OF A MARYLAND BIPOLAR FORCEPS INSTRUMENT, WHICH WAS THEN REMOVED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE OR ANYTHING ORDINARY WAS OBSERVED. THERE WAS NO TASK BEING PERFORMED BECAUSE THE CUSTOMER FOUND THIS ISSUE BEFORE CLOSURE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. IT WAS UNKNOWN IF THE INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENT OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THE WRIST WAS STRAIGHTENED. THE SURGICAL STAFF DID NOT NOTICE ANY OTHER DAMAGE TO THE INSTRUMENT AFTER THE EVENT OCCURRED. THE FRAGMENT WAS RETRIEVED VIA LAPAROSCOPY AND ALL FRAGMENT REMOVAL WAS RETRIEVED CONFIRMED VIA VISUAL. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THE PROCEDURE WAS ROBOTICALLY COMPLETED. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958733 ENDOWRIST SP MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430010-57 U11230302 0009 00886874114322

    Patients

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