BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 20992987 · Received December 20, 2024

    Report

    Report Number
    2955842-2024-23286
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    November 27, 2024
    Report Date
    November 26, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE IDLER PULLEYS. THE CABLE WAS FULLY BROKEN. A REVIEW OF AN IMAGE PROVIDED BY THE CUSTOMER OF THE INSTRUMENT WAS PERFORMED. THE IMAGE APPEARS TO SHOW A BROKEN GRIP CABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC PACING SURGICAL PROCEDURE, A WIRE ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO BE DAMAGED. A FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE. THE CASE WAS COMPLETED ROBOTICALLY USING A BACKUP MARYLAND BIPOLAR FORCEPS INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON DID NOT NOTICE ANY FUNCTIONALITY ISSUES WITH THE INSTRUMENT DURING USE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE CASE. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO BREAKAGE). THE WRIST WAS STRAIGHTENED UPON REMOVAL. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON THE REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA OR NOTICE ANY DAMAGE ON THE CANNULA AFTER THE EVENT OCCURRED. NO OTHER DAMAGE WAS NOTED TO THE INSTRUMENT AFTER THE EVENT. IT WAS VISUALLY CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT AND NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE INSTRUMENT IS AVAILABLE FOR ISI FAILURE ANALYSIS, HOWEVER, THE FRAGMENT HAS BEEN DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2393323 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-17 K11231214 0207

    Patients

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