BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 15956038 · Received December 10, 2022

    Report

    Report Number
    2955842-2022-15813
    Event Type
    Malfunction
    Date Received
    December 10, 2022
    Date of Event
    August 8, 2022
    Report Date
    November 9, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874121921
    PMA / PMN Number
    K211997
    Removal / Correction Number
    ISIFA2022-10-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SUREFORM 30 WHITE RELOAD INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BROKEN RELOAD TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. VISUAL INSPECTION WAS PERFORMED AND THE RELOAD WAS FOUND TO BE BROKEN AT THE PROXIMAL END. NO MATERIAL APPEARS TO BE MISSING. THE BROKEN RELOAD CAUSED THE SWITCH TO BE DISLODGED IN A HORIZONTAL POSITION RATHER THAN ITS USUAL VERTICAL POSITION. THIS FAILURE LIKELY CAUSED THE ERROR MESSAGE OBSERVED DURING IN-HOUSE TESTING STATING: "MISSING OR USED RELOAD INSTALLED REMOVE INSTRUMENT AND INSTALL NEW RELOAD." WHEN THE RELOAD WAS PLACED ON THE SYSTEM. THE RELOAD WAS RETURNED NOT FIRED. ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO THE USER. AN ADDITIONAL OBSERVATION NOT REPORTED BY SITE THAT IS RELATED TO THE CUSTOMER REPORTED COMPLAINT: THE RELOAD WAS FOUND TO HAVE A BENT SWITCH. THIS FAILURE IS LIKELY CAUSED BY THE BROKEN RELOAD. ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO THE USER. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS AVAILABLE FOR REVIEW. PROCEDURE LOGS CONFIRMED THAT THE CUSTOMER PERFORMED A TOTAL COLECTOMY PROCEDURE ON (B)(6) 2022 ON SYSTEM (B)(4). THE SUREFORM STAPLER 30 WHITE RELOAD WAS NOT FIRED AND DID NOT GET CAPTURED BY PROCEDURE LOGS AND AS A RESULT, A TOOL USAGE LOG COULD NOT BE PERFORMED TO DETERMINE WHEN THE RELOAD WAS LAST USED DURING A PROCEDURE. A REVIEW OF THE ADVANCED FAILURE ANALYSIS FOR THE SUREFORM 30 RELOAD ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE FAE STATED THAT THE DAMAGE WAS SIMILAR IN NATURE TO THE SUREFORM 30 RELOAD SWITCH FRAGMENT FAILURE MODE, IN THAT THE SWITCH AND CARTRIDGE TAIL DAMAGE WAS LIKELY CAUSED BY IMPROPER INSTALLATION. THE FAE PROVIDED A SLIDE IN THE EMAIL SHOWING THE IN-HOUSE ENGINEERING REPLICATION OF THE BROKEN SWITCH, WITH A FOCUS ON THE PICTURES AT THE TOP OF THE SLIDE SHOWING THE SWITCH BENDING. THE MAIN DIFFERENCE WITH THIS RETURNED RELOAD IS THAT IT APPEARS THAT THE RELOAD WAS NOT DETECTED DUE TO THE SWITCH DAMAGE, SO THE INSTRUMENT WASN¿T ABLE TO FIRE THIS RELOAD. THERE WERE TWO FAILURE MODES FOUND FOR THIS RELOAD, A BROKEN CARTRIDGE TAIL (WHITE PLASTIC MATERIAL) AND A BENT SWITCH (METAL COMPONENT). BOTH WERE LIKELY CAUSED BY IMPROPER INSTALLATION. IF THE RELOAD WAS ABLE TO BE DETECTED AS SHOWN IN AN IMAGE IN THE SLIDE, THERE WAS A POTENTIAL FOR A COMPLETE BREAK OF THE SWITCH AS SHOWN IN AN IMAGE IN THE SLIDE. IF IT WERE TO RECUR, IT COULD HAVE POTENTIALLY RESULTED IN FFIP. IT WAS CONFIRMED THAT THIS TYPE OF DAMAGE IS SIMILAR TO THE DAMAGE OBSERVED ON SUREFORM 30 RELOADS THAT RESULTED IN THE FIELD ACTION. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: FAILURE ANALYSIS ACKNOWLEDGES THAT IF THIS FAILURE REOCCURS IT COULD POTENTIALLY LEAD TO A FRAGMENT FALLING INTO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE WAS NO REPORT FROM THE CUSTOMER THAT A FRAGMENT FROM THE INSTRUMENT FELL INTO THE PATIENT DURING THE PROCEDURE. WHILE THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL COLECTOMY SURGICAL PROCEDURE, THE SUREFORM 30 WHITE RELOAD WAS NOT RECOGNIZED, YET THE BLUE RELOAD DID WORK. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THIS EVENT OCCURRED DURING A TOTAL COLECTOMY PROCEDURE ON (B)(6) 2022. THE REPORTED EVENT WAS THAT THE CUSTOMER WAS HAVING ISSUES WITH THE WHITE RELOAD BEING RECOGNIZED ON THE STAPLER. THEY HAD USED 2 WHITE RELOADS AND NONE OF THEM WERE RECOGNIZED BY THE STAPLER. THEY DECIDED THAT THEY WANTED TO PROCEED WITH THE PROCEDURE, SO THEY SWITCHED TO BLUE RELOADS AND IT WORKED. THERE WAS A DELAY OF ABOUT 15 MINUTES. THE CUSTOMER STATED THE WHITE RELOADS SEEM TO BE REALLY DELICATE. THE PROCEDURE WAS COMPLETED ROBOTICALLY AND THERE WAS NO PATIENT INJURY DUE TO THE ISSUE. PATIENT DEMOGRAPHICS AND IMAGES ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2544246 SUREFORM 8MM STAPLER GDW INTUITIVE SURGICAL, INC 48230W-02 U90220518 10886874121921

    Patients

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