BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 10618245 · Received October 1, 2020

    Report

    Report Number
    2955842-2020-11029
    Event Type
    Death
    Date Received
    October 1, 2020
    Date of Event
    September 4, 2020
    Report Date
    September 4, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    UDI-DI
    00886874116234
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE PHYSICIAN AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: IT WAS CONFIRMED THAT THE ION SYSTEM WORKED WITHOUT MALFUNCTIONS, AND REGISTRATION WAS BETTER THAN EXPECTED IN A LOWER LOBE. IT WAS REPORTED THAT THERE WAS A GOOD CORRELATION BETWEEN VIRTUAL AND REAL CAMERA VIEW AND MINIMAL CT-TO-BODY DIVERGENCE. THE FIRST TISSUE BIOPSY USING A BIOPSY NEEDLE WAS DONE, FOLLOWED BY A BRUSH CYTOLOGY. SOME ENDOLUMINAL BLEEDING WAS OBSERVED. AFTER THE DIAGNOSIS WAS RECEIVED FROM ROSE, THE PHYSICIAN TOOK ADDITIONAL BIOPSIES AND MOVED ON TO A MEDIASTINAL STAGING PROCEDURE USING EBUS-TBNA WITH NON-INTUITIVE PRODUCTS. ABOUT 10MIN IN TO THE PROCEDURE, THE PATIENT CODED. ENDULUMINAL BLEEDING WAS NOTED AND A BALLOON BLOCKER WAS USED IN THE LEFT LOWER LOBE. AT THAT TIME, SYSTEMIC EPINEPHRINE WAS REQUIRED TO HEMODYNAMICALLY STABILIZE THE PATIENT, WHICH ENHANCED ENDOLUMINAL BLEEDING. THE ESTIMATED BLOOD LOSS WAS APPROX. 600CC. THE BLOOD COAGULATION PROFILE AND PLATELETS WERE FINE. THE EBUS-TBNA PROCEDURE WAS TERMINATED IN ORDER TO STABILIZE THE PATIENT. THE FAMILY DECIDED TO END LIFE SUPPORT. MEDICAL REVIEW: A REVIEW OF THE EVENT WAS CONDUCTED BY AN ISI MEDICAL SAFETY OFFICER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: ALL TECHNOLOGIES THAT INTEND TO RETRIEVE TISSUE FROM THE LUNG CARRY THE RISK OF CAUSING A BLEEDING EVENT. THE PROGRAM DIRECTOR, WHO WAS ASSISTING DURING THE CASE, STATED THAT THE SYSTEM WAS WORKING PROPERLY, AND THE OUTCOME WAS ATTRIBUTABLE TO THE PATIENT'S OVERALL CONDITION AND THE INTERVENTION REQUIRING GENERAL ANESTHESIA. THEREFORE, THE EVENT WAS NOT CAUSED BY THE PRODUCT, BUT DUE TO THE INTENTION AND ACTION TO BIOPSY LUNG TISSUE. SITE HISTORY REVIEW: A REVIEW OF THE SITE'S COMPLAINT HISTORY DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS RELATED TO THE PRODUCT/EVENT. SYSTEM LOG REVIEW: LOGS ARE UNAVAILABLE FOR THIS DATE. IMAGE/VIDEO REVIEW: NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. FAILURE ANALYSIS REVIEW (NO RMA): FAILURE ANALYSIS INVESTIGATION IS NOT REQUIRED AS NO PRODUCT WAS RETURNED FOR THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT AFTER THE COMPLETION OF AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPIRED. THE PATIENT'S FAMILY MADE THE DECISION OF DNR (DO-NOT-RESUSCITATE) AND REQUESTED FOR THE PATIENT TO BE TAKEN OFF THE VENTILATOR. ALTHOUGH THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED, THE CAUSE OF THE BLEEDING IS UNKNOWN. THERE IS NO ALLEGATION THAT THE ION SYSTEM, INSTRUMENT, OR ACCESSORY MALFUNCTION OCCURRED DURING THE LUNG BIOPSY PROCEDURE. THE EXPIRATION DATE IS NOT APPLICABLE. IMPLANT DATE IS NOT APPLICABLE BECAUSE THE PRODUCT IS NOT IMPLANTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE COMPLETION OF AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPIRED. THE PATIENT'S FAMILY MADE THE DECISION OF DNR (DO-NOT-RESUSCITATE) AND REQUESTED FOR THE PATIENT TO BE TAKEN OFF THE VENTILATOR. THERE IS NO ALLEGATION THAT AN ION SYSTEM, INSTRUMENT, OR ACCESSORY MALFUNCTION OCCURRED DURING THE LUNG BIOPSY PROCEDURE. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI ENDOLUMINAL SALES REPRESENTATIVE (ESR), WHO WAS PRESENT DURING THE PROCEDURE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT WAS (B)(6) YEARS OLD, WHITE, AND FEMALE. IT WAS REPORTED AFTER THE ION ENDOLUMINAL LUNG BIOPSY PROCEDURE WAS COMPLETED WHICH LED TO THE DIAGNOSIS OF A 14MM LESION IN THE LEFT LOWER LOBE, THE ROBOT WAS UNDOCKED, AND THE PATIENT UNDERWENT A SUBSEQUENT ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) PROCEDURE (A MEDIASTINAL LYMPH NODE STAGING PROCESS) USING NON-INTUITIVE PRODUCTS TO ASSESS THE EXTENT OF THE DISEASE. WITHIN 10 MINUTES INTO THE EBUS-TBNA PROCEDURE, THE PATIENT CODED. THERE WERE SOME BLEEDING INDICATORS ON CONVENTIONAL FLUOROSCOPY (HAZINESS IN THE LEFT LOWER LOBE) AND INITIALLY LIMITED ENDOLUMINAL BLEEDING. CPR WAS PERFORMED, AND THE PROCEDURE WAS TERMINATED IN ORDER TO STABILIZE THE PATIENT. THE PATIENT WAS THEN TRANSFERRED TO THE ICU. WITHIN 30 MINUTES, THE PATIENT CODED AGAIN, CPR WAS PERFORMED, AND THE PATIENT WAS STABILIZED. THE PATIENT WAS ON A VENTILATOR. THE PATIENT'S FAMILY WAS INFORMED; THEY SEEMED TO DISTANCE THEMSELVES FROM LIFE-SUSTAINING MEASURES. THE FAMILY DECIDED TO END LIFE SUPPORT. THE SURGEON HAD REITERATED TO THE ESR THAT THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION PRODUCT OCCURRED OR CAUSED/CONTRIBUTED TO THE DEATH. THERE IS NO VIDEO RECORDING OF THE ROBOTIC PROCEDURE AVAILABLE FOR REVIEW. ON (B)(6) 2020, THE ASSISTING PHYSICIAN (AND THE SITE'S ION PROGRAM DIRECTOR) CONTACTED ISI'S MEDICAL OFFICER AND PROVIDED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE PATIENT WAS A FRAGILE, OLDER FEMALE WITH A SUSPICIOUS LUNG NODULE IN THE LEFT LOWER LOBE. THE PATIENT WAS SCHEDULED TO UNDERGO A ROBOTIC-ASSISTED BIOPSY FOR DIAGNOSTIC PURPOSES BY HIS COLLEAGUE. HE WAS ASKED TO ASSIST THE CASE. THE ION SYSTEM WORKED WITHOUT MALFUNCTIONS, AND REGISTRATION WAS BETTER THAN EXPECTED FOR A LOWER LOBE NODULE LOCATION. IT WAS REPORTED THAT THERE WAS A GOOD CORRELATION BETWEEN VIRTUAL AND REAL CAMERA VIEW AND MINIMAL CT-TO-BODY DIVERGENCE. FIRST A TISSUE BIOPSY USING A BIOPSY NEEDLE WAS PERFORMED, FOLLOWED BY A BRUSH CYTOLOGY. INITIALLY, SOME ENDOLUMINAL BLEEDING WAS OBSERVED. AFTER A DIAGNOSIS WAS RECEIVED FROM ROSE, THE INTERVENTIONAL PULMONOLOGIST TOOK ADDITIONAL BIOPSIES AND MOVED ON TO A MEDIASTINAL STAGING PROCEDURE USING EBUS-TBNA. ABOUT 10 MINUTES IN, THE PATIENT CODED. MORE EXTENDED BLEEDING WAS NOTED IN THE LEFT LOWER LOBE AND A BALLOON BLOCKER WAS USED TO CONTROL THE HEMORRHAGE. AT THAT TIME, SYSTEMIC EPINEPHRINE WAS REQUIRED TO STABILIZE VITAL SIGNS, WHICH ENHANCED ENDOLUMINAL BLEEDING. THE FINAL ESTIMATED BLOOD LOSS WAS APPROX. 600CC. THE BLOOD COAGULATION PROFILE AND PLATELETS WERE FINE. THE EBUS-TBNA PROCEDURE WAS TERMINATED IN ORDER TO STABILIZE THE PATIENT. THE FAMILY DECIDED TO END LIFE SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076656 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-43 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death DA VINCI INSTRUMENTS AND ACCESSORIES| DA VINCI INSTRUMENTS AND ACCESSORIES