BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 12694295 · Received October 25, 2021

    Report

    Report Number
    2955842-2021-11382
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    September 29, 2021
    Report Date
    September 29, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874117597
    PMA / PMN Number
    K190999
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED ISSUE IS RELATED TO USER ERROR. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE CONSOLE SURGEON STATED THAT NO MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTATION, OR ACCESSORIES WAS ASSOCIATED WITH THE REPORTED INCIDENT. THEREFORE, NO PRODUCTS ARE EXPECTED TO BE RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE SUREFORM 45 STAPLER INSTRUMENT, AND THE RELOADS RETURNED; HOWEVER, THE PRODUCTS HAVE BEEN DISCARDED. SYSTEM LOG REVIEWS WERE CONDUCTED AND THE FOLLOWING INFORMATION WAS PROVIDED: ALL OF THE ERRORS IN THE LOGS FOR THE PROCEDURE ON (B)(6) 2021 ARE SYSTEM SERVICE ADVISORY. NONE OF THESE SUGGEST A PRODUCT ISSUE. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES REVEAL ANY ADDITIONAL COMPLAINTS FOR THIS PRODUCT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED LEFT LOWER PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SURGEON NOTICED THAT HE HAD CUT THE WRONG BLOOD VESSEL WITH A STAPLER INSTRUMENT. THEREFORE, THE SURGEON CONVERTED THE PROCEDURE TO AN OPEN PROCEDURE. A CARDIOVASCULAR SURGEON RECONSTRUCTED AND REPAIRED THE VESSEL. THE SURGEON CONFIRMED THAT THE VESSEL WAS MISIDENTIFIED AND ACCIDENTALLY CUT. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE ACTUAL EVENT DATE IS UNKNOWN. THE EXPIRATION DATE IS NOT APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT LOWER PULMONARY LOBECTOMY SURGICAL PROCEDURE, THINGS WERE GOING WELL, BUT THE SURGEON NOTICED THAT HE HAD CUT THE WRONG BLOOD VESSEL WITH A STAPLER. THEREFORE, THE SURGEON CONVERTED THE PROCEDURE TO AN OPEN PROCEDURE TO RECONSTRUCT THE BLOOD VESSEL. A CARDIOVASCULAR SURGEON WAS ALSO CALLED IN FOR RECONSTRUCTION. THE SURGEON STATED THAT "THE RUNNING OF THE BLOOD VESSELS WAS DIFFERENT FROM WHAT I HAD ASSUMED BEFORE THE PROCEDURE. IT DIDN'T MATTER IF IT WAS DA VINCI OR NOT; IT WAS UNEXPECTED." ON 30-SEP-2021, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON VIA AN ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SUREFORM 45 STAPLER INSTRUMENT DID NOT MALFUNCTION; HOWEVER, THE INSTRUMENT WAS IN USE WHEN THE SURGEON CUT THE SUPERIOR PULMONARY VEIN BY MISTAKE. IT WAS CONFIRMED THAT A CARDIAC SURGEON REPAIRED AND RECONSTRUCTED THE INJURED VESSEL. THE ESTIMATED BLOOD LOSS WAS UNKNOWN, AND THERE WAS NO BLOOD TRANSFUSION RENDERED TO THE PATIENT. THE SURGEON CONFIRMED THE FOLLOWING ADDITIONAL INFORMATION RELATED TO THE EVENT. THE ARMS OF THE ROBOT DID NOT MOVE TO CAUSE OR CONTRIBUTE TO THE INJURY. THE VESSEL WAS MISIDENTIFIED, AND THE SURGEON ACCIDENTALLY CUT THE WRONG VESSEL. THERE WAS NO ALLEGATION OF AN ISI DEVICE OR SYSTEM MALFUNCTION. ALTHOUGH IT WAS STATED THERE WERE ISSUES WITH THE VISION THAT CONTRIBUTED TO THE INJURY, IT WAS CONFIRMED THERE WAS NO MALFUNCTION OF THE SYSTEM, AND IT WAS ANATOMY-RELATED. THE SURGEON DID NOT TAKE IN MORE TISSUE INTO THE JAWS OF THE SUREFORM 45 STAPLER INSTRUMENT WITH THE INTENT OF STAPLING AND CUTTING, WHICH COULD HAVE CAUSED THE INJURY. THE PATIENT WAS REPORTED TO BE RECOVERING WELL WITH NO REPORT OF POSTOPERATIVE COMPLICATIONS. PATIENT-RELATED DETAILS WERE REQUESTED; HOWEVER, THE SITE WAS UNWILLING TO PROVIDE THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588290 SUREFORM SUREFORM 45 CURVED-TIP GDW INTUITIVE SURGICAL, INC 480545-04 L91201130 10886874117597

    Patients

    Seq Age Sex Outcome Treatment
    1