BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 19473945 · Received June 5, 2024

    Report

    Report Number
    2955842-2024-15520
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    May 15, 2024
    Report Date
    May 15, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874117597
    PMA / PMN Number
    K190999
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT WITH THE CUSTOMER REPORTED ISSUE TO PERFORM FAILURE ANALYSIS AND AN INVESTIGATION TO DETERMINE THE CAUSE OF THE REPORTED EVENT IS CURRENTLY IN PROGRESS. A REVIEW OF THE INSTRUMENT LOG FOR THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT ASSOCIATED WITH THE EVENT WAS PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). LOGS SHOW THE INSTRUMENT WAS INSTALLED ON THE SYSTEM TWICE AND FIRED ONE BLUE RELOAD. ON THE FIRST INSTALL, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. ON THE SECOND INSTALL, A WHITE RELOAD WAS LOADED, HOWEVER NO CLAMPING OR FIRING WAS PERFORMED. THE INSTRUMENT WAS THEN REMOVED AND NOT USED IN THE PROCEDURE AGAIN. THERE WERE NO STAPLER RELATED ERRORS IN THE LOGS CORRELATING TO THE INSTRUMENT. THERE WAS ONE SUCCESSFUL UNCLAMPING EVENT AND NO UNCLAMPING FAILURES.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS AND DID NOT CONFIRM THE CUSTOMER REPORTED ISSUE. A VISUAL INSPECTION OF THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE CHANNEL SPRANG BACK OPEN WHEN IN THE UNCLAMPED STATE AND THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS, AND THE GRIPS OPENED AND CLOSED PROPERLY ON MULTIPLE ATTEMPTS. THE STAPLER INSTRUMENT WAS TESTED IN-HOUSE AND INITIALIZED, CLAMPED, FIRED, AND UNCLAMPED WITHOUT ANY ISSUES. THE STAPLER INSTRUMENT FIRED SUCCESSFULLY TWICE USING THE SUREFORM 45 WHITE RELOAD ACCESSORY THAT IT WAS RETURNED WITH AND ONE IN-HOUSE SUREFORM 45 BLUE RELOAD ACCESSORY. A REVIEW OF INSTRUMENT LOG WAS ALSO UNABLE TO VERIFY ANY FAILURES. A VISUAL INSPECTION OF THE SUREFORM 45 WHITE RELOAD ACCESSORY RETURNED WITH THE STAPLER INSTRUMENT DISPLAYED NO SIGNS OF PHYSICAL DAMAGE TO THE CARTRIDGE, KNIFE, PUSHERS, OR COVER. THE RELOAD ACCESSORY ATTACHED TO AND REMOVED FROM THE STAPLER INSTRUMENT WITHOUT ANY ISSUES. THE RELOAD ACCESSORY COVER WAS REMOVED AND INSPECTED AFTER FIRING THE STAPLER INSTRUMENT AND THERE WAS NO DAMAGE IDENTIFIED TO THE RELOAD ACCESSORY OR ITS COMPONENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED APPENDECTOMY SURGICAL PROCEDURE, THE CUSTOMER LOADED A WHITE RELOAD INTO THE SUREFORM 45 CURVED-TIP STAPLER INSTRUMENT AND ELECTED TO CHANGE TO A BLUE RELOAD, HOWEVER, THE JAWS OF THE STAPLER INSTRUMENT WOULD NOT OPEN. THE PROCEDURE WAS COMPLETED UTILIZING A BACK-UP DA VINCI INSTRUMENT OF THE SAME KIND WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE STAPLER INSTRUMENT WAS INSERTED INTO THE PATIENT, AFTER WHICH, THE SURGEON CHOSE TO UTILIZE A DIFFERENT SIZE RELOAD PRIOR TO THE STAPLER ENGAGING TISSUE. UPON REMOVAL OF THE STAPLER, THE STAFF WAS UNABLE TO OPEN THE JAWS OF THE INSTRUMENT TO REMOVE THE UNFIRED RELOAD. CONSEQUENTLY, A NEW STAPLER INSTRUMENT WAS OPENED AND THE PROCEDURE WAS CONTINUED AS PLANNED. THE JAWS OF THE STAPLER INSTRUMENT WERE NOT STUCK ON TISSUE OR A VESSEL WHEN THE ISSUE OCCURRED, AND THERE WAS NO UNEXPECTED TISSUE REMOVAL OR BLEEDING AS A RESULT OF THE INCIDENT. THE STAPLER INSTRUMENT FUNCTIONED APPROPRIATELY PRIOR TO THE INCIDENT AND IT WAS CONFIRMED THAT NO STAPLER FIRE WAS INVOLVED WITH THE REPORTED EVENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138 SUREFORM SUREFORM 45 CURVED-TIP GDW INTUITIVE SURGICAL, INC 480545-04 L10230223 0052 10886874117597

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES