BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 16774295 · Received April 20, 2023

    Report

    Report Number
    2955842-2023-12075
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    March 22, 2023
    Report Date
    March 24, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874117092
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE STAPLES MISSING FROM THE LINE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI SURE FORM 45 GREEN RELOAD TO PERFORM FAILURE ANALYSIS. THE SURE FORM 45 GREEN RELOAD WAS ANALYZED AND FOUND TO HAVE THE KNIFE EXPOSED WITHIN THE KNIFE TRACK. THE RELOAD WAS FOUND TO HAVE A FIRING FAILURE BASED ON LOG REVIEW AND WAS OBSERVED DURING IN-HOUSE OBSERVATIONS. ALTHOUGH INITIAL INVESTIGATION DETERMINED THE MOST PROBABLE COMMON CAUSE TO BE NOT DETERMINABLE/APPLICABLE, AFTER AN ADDITIONAL INVESTIGATION FOR RELOAD WITHOUT BLADE DAMAGE, THE MOST PROBABLE COMMON CAUSE IS DETERMINED TO BE COMPONENT FAILURE. COMMON CAUSES OF THE FAILURE MODE EXPOSED COMPONENT RELOADS ARE TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE. EXAMPLE: FIRING ACROSS A STAPLE LINE OR OTHER OBSTRUCTIONS. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS ALSO IDENTIFIED: THE RELOAD WAS OBSERVED TO BE PARTIALLY FIRED. THE RELOAD WAS DISASSEMBLED IN-HOUSE AND THE CARTRIDGE APPEARED TO BE SLIGHTLY DAMAGED WITHIN THE KNIFE TRACK. THE DAMAGES WITHIN THE KNIFE TRACK WERE OBSERVED NEAR THE LOCATION OF THE EXPOSED COMPONENT. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO MISHANDLING/MISUSE. THIS COMPLAINT IS REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT STAPLES WERE MISSING FROM THE STAPLE LINE WITH UNKNOWN CAUSE. IF NOT RECOGNIZED DURING THE PROCEDURE, MEDICAL INTERVENTION, INCLUDING ADDITIONAL SURGICAL PROCEDURES, MAY BE REQUIRED IN THE EVENT THAT THE STAPLES ARE NOT DELIVERED FROM THE RELOAD. WHILE THERE WAS NO 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 DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT WAS FIRING ACROSS A BRONCHUS AND RECEIVED AN ERROR MESSAGE STATING THE TISSUE WAS TOO THICK. THE INSTRUMENT WAS STOPPED, UNCLAMPED AND THE BLADE WAS EXPOSED. THE CUSTOMER WAS UNABLE TO REMOVE THE RELOAD. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SUREFORM 45 STAPLER INSTRUMENT WAS INSPECTED PRIOR TO USED AND NO DAMAGE WAS OBSERVED. THE GREEN RELOAD WAS USED AND IT WAS CHOSEN DUE TO THE THICKNESS OF THE TISSUE. THE STAPLER INSTRUMENT PARTIALLY FIRED, COMPRESSED, AND UNCLAMPED DUE TO THE TISSUE BEING TOO THICK. THE SURGEON WAS STAPLING ACROSS THE BRONCHUS AT THE TIME OF THE EVENT. THE ISSUE DID NOT INVOLVE A FAILURE TO FIRE. THE EVENT DID INVOLVE A PARTIAL FIRE. THE EVENT DID NOT INVOLVE TISSUE BEING PUSHED FORWARD/DRAGGED DURING THE FIRING PROCESS. THE STAPLER INSTRUMENT JAWS OPENING/RELEASING DURING THE FIRING SEQUENCE AFTER THE PARTIAL FIRE. THE STAPLING ISSUE DID NOT RESULT IN MALFORMED OR UNIFORMED STAPLES. THE STAPLING ISSUE DID RESULT IN THE RELOAD HAVING AN EXPOSED BLADE. THE STAPLING ISSUE DID RESULT IN STAPLES MISSING FROM THE STAPLE LINE. THERE WERE NO HOLES/GAPS OBSERVED WITHIN THE STAPLER LINE. THE RELOAD WAS NOT STUCK TO TISSUE. THE FOLLOWING ERRORS/MESSAGES WERE GENERATED WHEN THE STAPLING ISSUE OCCURRED: UNABLE TO FIRE, BLADE EXPOSED, TISSUE TOO THICK. THE SURGEON DID NOT ENCOUNTER ANY OBSTRUCTIONS SUCH AS CLIPS, STAPLES, OR OTHER HARD MATERIAL BETWEEN THE INSTRUMENT JAWS. THE SURGEON DID NOT FIRE OVER AN EXISTING STAPLE LINE. BUTTRESS MATERIAL WAS NOT USED. THE SURGEON DID NOT EXPERIENCE ANY CLAMPING ISSUE PRIOR TO FIRING THE STAPLER RELOAD. NO BLEEDING WAS OBSERVED DUE TO THE STAPLER INSTRUMENT ISSUE. THERE WAS NO UNPLANNED TISSUE REMOVAL DUE TO THE STAPLER INSTRUMENT FIRING FAILURE. THE SURGEON USED A BACKUP STAPLER INSTRUMENT TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591800 SUREFORM SUREFORM 45 RELOAD GREEN GDW INTUITIVE SURGICAL, INC 48345G-01 T91220604 10886874117092

    Patients

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