BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOWRIST

    MDR report key: 13358179 · Received January 26, 2022

    Report

    Report Number
    2955842-2022-10121
    Event Type
    Death
    Date Received
    January 26, 2022
    Date of Event
    December 29, 2021
    Report Date
    May 23, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119778
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A MEDICAL REVIEW WAS PERFORMED BY AN ISI MEDICAL SAFETY OFFICER AND THE FOLLOWING INFORMATION WAS PROVIDED: "BASED UPON THE LIMITED INFORMATION IN THE DESCRIPTION OF EVENTS, THE CAUSE OF THE PULMONARY ARTERY DAMAGE CANNOT BE DETERMINED." AN ISI TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS FOR THIS PROCEDURE AND PROVIDED THE FOLLOWING INFORMATION: ERROR 100 WAS OBSERVED ON SET-UP JOINT (SUJ) 1 AND INDICATED THE ARM MAY HAVE MOVED WITHOUT BEING CLUTCHED. THE TSE RECOMMENDED THE FIELD SERVICE ENGINEER (FSE) PERFORM A MANUAL FRICTION TEST ON SUJ1. AN ISI FSE WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE REPORTED COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION. THE SYSTEM PASSED THE MANUAL FRICTION TEST. SYSTEM VERIFICATION TESTED WAS PERFORMED WITH NO OBSERVED ERRORS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AS OF THE DATE OF THIS REPORT, FIVE PROCEDURES HAVE BEEN PERFORMED ON THIS SYSTEM SINCE THE DATE OF THIS REPORTED EVENT. THE TSE PROVIDED THE FOLLOWING STATEMENT: ¿BASED ON SITE REVIEW, 3 PROCEDURES WERE COMPLETED THE WEEK AFTER THE EVENT WITH NO COMPLAINTS REPORTED." A REVIEW OF THE INSTRUMENT LOGS FOR THE PROCEDURE DATE OF (B)(6) 2021 HAS BEEN PERFORMED AND THE FOLLOWING WAS OBSERVED: THE LONG BIPOLAR GRASPER AND CURVED-TIP STAPLER 30 INSTRUMENTS HAD NO USES REMAINING AND THEREFORE WERE NOT REUSED IN SUBSEQUENT PROCEDURES. THE CADIERE FORCEPS (PART #471049-08/ LOT #N13210802-0009/ USES REMAINING: 17) AND TIP-UP FENESTRATED GRASPER (PART #470347-11/ LOT #N10210125-0187/ USES REMAINING: 4) HAVE USES REMAINING, BUT HAVE NOT BEEN REUSED IN SUBSEQUENT PROCEDURES. BOTH OF THE ENDOSCOPES (30 DEGREE AND A 0 DEGREE) USED DURING THIS PROCEDURE HAVE BEEN USED IN SUBSEQUENT PROCEDURES. THERE ARE NO SEPARATE COMPLAINTS AGAINST ANY OF THE INSTRUMENTS OR ENDOSCOPES USED DURING THIS PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT A PATIENT UNDERWENT A DA VINCI-ASSISTED PROCEDURE AND THE PULMONARY ARTERY WAS DAMAGED. THE PATIENT LATER EXPIRED IN THE ICU. THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

    Additional Manufacturer Narrative · 0

    ON 15-MAY-2022, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON: THE CADIERE FORCEPS INSTRUMENT WAS DIRECTLY USED/CAME INTO CONTACT WITH THE PULMONARY ARTERY TO CAUSE THE INJURY. THE SURGEON INDICATED THAT THEY WERE DISSECTING BEHIND A PULMONARY ARTERY BRANCH WITH THE CADIERE FORCEPS WHEN THE PULMONARY ARTERY WAS INJURED, BUT IT IS UNCLEAR WHY THE INJURY OCCURRED BECAUSE THERE WERE NO APPARENT ADHESIONS, DIFFICULTY WITH DISSECTION, OR MALFUNCTIONING INSTRUMENTS. THE SURGEON CANNOT IDENTIFY THE CAUSE. THE SURGEON REPORTED THAT THEY DO NOT THINK THAT A DA VINCI SYSTEM, INSTRUMENT, AND/OR ACCESSORY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE SURGEON STATED THAT THE FOLLOWING INTERVENTION WAS PERFORMED TO RESOLVE THE INJURY: "CONVERTING TO THORACOTOMY THEN PLACED ON VENOVENOUS (VV) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), PULMONARY ARTERY REPAIRED." "ABOUT 25 UNITS PACKED RED BLOOD CELLS (PRBC)" WERE ADMINISTERED DUE TO THIS EVENT. THE PATIENT EXPIRED FOURTEEN (14) DAYS AFTER THE PROCEDURE. WHEN ASKED FOR THE ULTIMATE CAUSE OF DEATH, THE SURGEON RESPONDED WITH "TRANSITIONED TO COMFORT CARE." IT WAS REPORTED THAT ISI CANNOT OBTAIN A COPY OF THE AUTOPSY REPORT. NO PHOTOS AND/OR VIDEOS OF THIS EVENT WERE AVAILABLE FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT PULMONARY LOBECTOMY PROCEDURE THE PATIENT'S PULMONARY ARTERY WAS DAMAGED. THE PATIENT CODED AND LATER PASSED AWAY IN THE INTENSIVE CARE UNIT (ICU) ON AN UNSPECIFIED DATE. THIS EVENT WAS INITIALLY REPORTED BY A CHARGE NURSE AT THE SITE. INTUITIVE SURGICAL, INC. (ISI) PERFORMED MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON OF THIS PROCEDURE. HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    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
    703051 ENDOWRIST CADIERE FORCEPS NAY INTUITIVE SURGICAL, INC 471049-08 N13210802 0009 00886874119778

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.| DA VINCI INSTRUMENTS AND ACCESSORIES.