BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 20309529 · Received September 26, 2024

    Report

    Report Number
    2955842-2024-19781
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    August 28, 2024
    Report Date
    August 28, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE EITHER OF THE LARGE CLIP APPLIER INSTRUMENTS THAT WERE USED DURING THIS REPORTED EVENT; THEREFORE, FAILURE ANALYSIS INVESTIGATIONS COULD NOT BE PERFORMED. NO FIELD SERVICE ACTION WAS REQUIRED AS THE SYSTEM WAS READY FOR USE AFTER THE INSTRUMENT WAS CORRECTLY RESEATED. A REVIEW OF THE INSTRUMENT LOG SHOWS THERE WERE 2 LARGE CLIP APPLIER INSTRUMENTS USED DURING THE PROCEDURE; AND HAVE SINCE BEEN USED AGAIN: LARGE CLIP APPLIER INSTRUMENT (LOT NUMBER: K10240418-0491) ASSOCIATED WITH THIS EVENT WAS PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON 9/11/2024 ON SYSTEM SK5288. THE INSTRUMENT HAD 78 USES REMAINING AFTER LAST USE. LARGE CLIP APPLIER INSTRUMENT (LOT NUMBER: K11230727-0156) ASSOCIATED WITH THIS EVENT WAS PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON 9/03/2024 ON SYSTEM SK5288. THE INSTRUMENT HAD 18 USES REMAINING AFTER LAST USE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: TOOL INVALID REASON: ONE OR MORE TOOL SENSORS WERE NOT DETECTED: ONLY TOOL MAGNET DETECTED ON UNIVERSAL SURGICAL MANIPULATOR 4. A REVIEW OF THE PROVIDED VIDEO WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL DEVELOPMENT ENGINEER, AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE VIDEO SHOWS THE GASTRIC ARTERY BEING HELD WITH A FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT. AT 0:11, A LARGE CLIP APPLIER INSTRUMENT IS INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR 4 AND AN ARMPOD MESSAGE APPEARS INSTRUCTING THE USER TO ADVANCE THE INSTRUMENT TO RETURN TO ITS PREVIOUS LOCATION. THE INSTRUMENT IS ADVANCED AND THE JAWS ARE PLACED AROUND THE ARTERY. AT 0:26, AN ¿ARM NOT READY¿ ERROR OCCURS, INSTRUCTING THE USER TO REMOVE THE INSTRUMENT. WHEN THE INSTRUMENT IS REMOVED, INTERACTION WITH THE CLIP CAUSES SOME BLEEDING TO THE ARTERY, WHICH IS CONTROLLED WITH PRESSURE FROM THE FBF. AS CONFIRMED BY THE TECHNICAL SUPPORT ENGINEER, THIS MESSAGE CAN APPEAR WHEN THE INSTRUMENT IS NOT FULLY ENGAGED WITH THE STERILE ADAPTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE, THE PATIENT WAS INJURED WHILE REMOVING THE LARGE CLIP APPLIER INSTRUMENT TO RESEAT THE INSTRUMENT ON THE UNIVERSAL SURGICAL MANIPULATOR 4 (USM4). WHEN THE EVENT OCCURRED, THE SURGEON WAS ATTEMPTING VASCULAR CONTROL OF THE GASTRIC ARTERY, WHEN THE LED LIGHT ON USM4, CHANGED TO AN AMBER COLOR AND AN ERROR MESSAGE WAS OBSERVED STATING "ARM NOT READY. REMOVE INSTRUMENT TO CONTINUE". WHILE REMOVING THE LARGE CLIP APPLIER INSTRUMENT, THE CLIP WAS PARTIALLY PULLED ON THE GASTRIC ARTERY CAUSING A MINOR BLEED. THE BLOOD LOSS WAS ESTIMATED TO BE APPROXIMATELY 10MLS, WHICH WAS RESOLVED BY USING THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TO HOLD PRESSURE. THE LARGE CLIP APPLIER INSTRUMENT WAS RESEATED, AND CLIPS WAS APPLIED SUCCESSFULLY, HELPING TO CONTROL THE BLEEDING AND A VESSEL SEALER EXTEND INSTRUMENT WAS USED FOR THE ARTERY LIGATION AS PLANNED. THE PATIENT DID NOT REQUIRE A TRANSFUSION OF BLOOD PRODUCTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY AND THERE WERE NO POST-OPERATIVE COMPLICATIONS. A TECHNICAL SUPPORT ENGINEER (TSE) WAS CALLED AND VERIFIED IN THE LOGS THAT THE LARGE CLIP APPLIER INSTRUMENT WAS NOT PROPERLY SEATED AND ENGAGED. THE CLINICAL SALES REPRESENTATIVE UNDERSTOOD WHY THE ISSUE OCCURRED AND WOULD BE CHECKING TO ENSURE THE INSTRUMENTS ARE PROPERLY ENGAGED DURING THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244492 ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470230 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES