BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUREFORM

    MDR report key: 18373336 · Received December 21, 2023

    Report

    Report Number
    2955842-2023-21579
    Event Type
    Death
    Date Received
    December 21, 2023
    Date of Event
    November 22, 2023
    Report Date
    November 30, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUMENTS NOTED BELOW WERE USED DURING THE REPORTED PROCEDURE. REVIEW OF THE INSTRUMENT LOGS FOUND THE FOLLOWING MULTIPLE-USE INSTRUMENTS WERE USED IN SUBSEQUENT PROCEDURES WITH NO REPORTED COMPLAINTS: ENDOSCOPE PLUS 0 DEGREE CAMERA, FENESTRATED BIPOLAR FORCEPS, MARYLAND BIPOLAR FORCEPS, SMALL GRASPING RETRACTOR, PERMANENT CAUTERY SPATULA, AND AN ENDOWRIST STAPLER 30 CURVED-TIP. THE SUREFORM 45 STAPLER IS A SINGLE-USE INSTRUMENT. STAPLER LOG REVIEW SHOWED THAT THE ENDOWRIST 30 CURVED-TIP STAPLER INSTRUMENT WAS USED FIRST DURING THE PROCEDURE. IT WAS INSTALLED ON THE SYSTEM TWICE WITH WHITE RELOADS; BOTH FIRINGS WERE COMPLETED SUCCESSFULLY. THE SUREFORM 45 STAPLER LOGS SHOWED ALL FIRINGS WERE COMPLETED AND THERE WERE NO STAPLER RELATED ERRORS IN EITHER OF THE STAPLER LOGS. REVIEW OF THE SYSTEM LOGS FOUND NO ERRORS LOGGED DURING THE PROCEDURE. THE SYSTEM HAS BEEN USED MULTIPLE TIMES SUBSEQUENT TO THE REPORTED EVENT; THE LOGS FOR THE SUBSEQUENT 5 PROCEDURE PERFORMED WERE ALSO REVIEWED WITH NO ERRORS FOUND. A DEVICE HISTORY RECORD REVIEW FOR THE INSTRUMENTS CONFIRMED THAT THERE WERE NO RELATED NON-CONFORMANCES DOCUMENTED. A REVIEW OF THE EVENT BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE PATIENT HAD A PULMONARY SEGMENTECTOMY WHERE AN INTUITIVE STAPLER WAS USED TO STAPLE AND DIVIDE THE PULMONARY ARTERY LEADING TO THE SEGMENT. THE PATIENT HAD A CATASTROPHIC BLEEDING EVENT 2 DAYS LATER AND DIED AS A RESULT OF THE BLEEDING. AN AUTOPSY DEMONSTRATED THE PULMONARY ARTERY STAPLE LINE HAD FAILED. THERE IS SUFFICIENT EVIDENCE TO SUGGEST AN INTUITIVE SURGICAL STAPLER PRODUCT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNEVENTFUL DA VINCI-ASSISTED PULMONARY APICAL SEGMENTECTOMY PROCEDURE. THE PATIENT LATER DEVELOPED BLEEDING AND EXPIRED. THE SURGEON STATED THAT THE PROCEDURE WAS DIFFICULT AS THE PATIENT HAD ADHESIONS DUE TO A PREVIOUS STAB WOUND; HOWEVER, THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. THE PA BRANCH WAS APPROXIMATELY 1CM AND WAS STAPLED WITH A SUREFORM 45 STAPLER INSTRUMENT WITH A BLUE RELOAD. NO ERRORS, MISFIRES, OR BLEEDING OCCURRED DURING THE STAPLE LINE FIRING. THE PATIENT HAD A HISTORY OF PULMONARY HYPERTENSION AND A PACEMAKER AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) POST-PROCEDURE. THE PATIENT WAS IN GOOD CONDITION AND WAS UP AND WALKING AROUND. HOWEVER, TWO DAYS POSTOPERATIVELY, THE PATIENT BECAME HYPOTENSIVE AND HAD INCREASED BLEEDING FROM THE CHEST TUBE. THE PATIENT CODED AND WAS RESUSCITATED WITH RETURN OF A PULSE; A CENTRAL LINE AND ARTERIAL LINE WERE PLACED AND RAPID BLOOD TRANSFUSIONS WERE ADMINISTERED. ULTIMATELY, THE PATIENT EXPIRED. THE TOTAL BLOOD LOSS WAS APPROXIMATELY 1.5 LITERS FROM THE CHEST TUBE, AND APPEARED TO BE PULMONARY ARTERIAL BLOOD. THE SURGEON STATED THAT ON THE MORNING OF THE EVENT, A CHEST X-RAY SHOWED THE CHEST TUBE POSITION WAS PULLED BACK APPROXIMATELY 2CM, BUT THAT WAS NOT A CONCERN. AN AIR LEAK WAS ALSO IDENTIFIED AND WAS ADDRESSED WITH A WATER SEAL CHEST TUBE. THE SURGEON STATED THAT HE DID NOT KNOW WHY THIS EVENT OCCURRED; HOWEVER, BASED ON INFORMATION FROM THE PATHOLOGIST WHO PERFORMED THE AUTOPSY AND A PHOTO PROVIDED, IT APPEARED THAT THE SUREFORM 45 STAPLE ON THE PA HAD COME UNDONE, OR WAS NOT PROPERLY FORMED. WHEN THE PATHOLOGIST SPRAYED SALINE INTO THE PA DURING THE AUTOPSY, THE SALINE CAME OUT OF THE PA WHERE THE STAPLE LINE WAS LOCATED. NO OTHER STAPLE LINE ISSUES WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2169368 SUREFORM SUREFORM 45 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48345B-01 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Unknown DA VINCI INSTRUMENTS AND ACCESSORIES