BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST SP

    MDR report key: 20530438 · Received October 25, 2024

    Report

    Report Number
    2955842-2024-21059
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    September 30, 2024
    Report Date
    September 30, 2024
    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
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS RETURNED AND FAILURE ANALYSIS TESTING WAS PERFORMED. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN MOLDED INSULATOR. BROKEN PIECES, MEASURING APPROXIMATELY 2.85MM X 7.95MM, 1.93MM X 1.33MM, AND 4.64MM X 1.87MM IN SIZES, WERE RETURNED WITH THE INSTRUMENT. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED GRIP TIP. THE DISLODGED GRIP TIP, MEASURING APPROXIMATELY 4.64MM X 14.36MM, WAS RETURNED WITH THE INSTRUMENT. ALSO, 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 INSULATION. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST, CONFIRMING A COMPLETE BREAK IN THE WIRE. NO THERMAL DAMAGE WAS FOUND ON THE INSTRUMENT. COMPONENTS ADJACENT TO THE BROKEN WIRE SHOW DAMAGE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS AS OF THE DATE OF THIS REPORT. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE INSTRUMENT APPEARS TO HAVE A BROKEN MOLDED INSULATOR ON ONE OF THE GRIPS, THE INSTRUMENT WOULD NEED TO BE RETURNED TO DETERMINE IF ALL OF THE FRAGMENTS ARE PRESENT. ROOT CAUSE OF THE FAILURE MODE CANNOT BE CONFIRMED PRIOR TO THE RETURN AND ANALYSIS OF THE INSTRUMENT.

    Additional Manufacturer Narrative · 0

    INITIAL FAILURE ANALYSIS (FA) WAS CONFIRMED BY AN INTUITIVE SURGICAL, INC. (ISI) ADVANCE FAILURE ANALYSIS ENGINEER. THE INSTRUMENT EXHIBITED A BROKEN MOLDED INSULATOR, WHICH RESULTED IN THE GRIP BECOMING DISLODGED. THE INSTRUMENT WAS TRANSFERRED FOR FURTHER INSPECTION AND NO ADDITIONAL FINDINGS WERE OBSERVED, BOTH GRIPS DID NOT APPEAR TO EXHIBIT BENDING AND THE GRIP WITH AN INTACT MOLDED INSULATOR DID NOT APPEAR TO HAVE OTHER DAMAGE.

    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 FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO HAVE THE TIP BROKEN. THE BROKEN FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: AFTER THE CUSTOMER USED THE INSTRUMENT FOR ABOUT AN HOUR, THE INSTRUMENT BROKE AND THE FRAGMENTS FELL INTO THE PATIENT. ALL THE FRAGMENTS WERE RETRIEVED DURING SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. THE CUSTOMER ALSO PERFORMED AN X-RAY TEST TO CONFIRM. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS AND WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. NO OTHER DAMAGE WAS NOTED ON THE INSTRUMENT AFTER THE EVENT OCCURRED, AND THE CANNULA HAD NO ISSUE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092897 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-57 U10230913 0025 00886874114339

    Patients

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