BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION

    MDR report key: 14780300 · Received June 22, 2022

    Report

    Report Number
    2955842-2022-12285
    Event Type
    Death
    Date Received
    June 22, 2022
    Date of Event
    May 19, 2022
    Report Date
    May 23, 2022
    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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. HOWEVER, THE DOCTOR INDICATED THAT HE BELIEVES THE BLEED WAS LIKELY DUE TO VASCULAR/NECROTIC TISSUE THAT WAS BIOPSIED AND THAT THE BLEEDING WOULD HAVE OCCURRED VIA ANOTHER LUNG BIOPSY MODALITY. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. PER AN ISI SENIOR FAILURE ANALYSIS ENGINEER, A REVIEW OF THE SYSTEM LOGS CANNOT BE PERFORMED AS THE SYSTEM LOGS ARE NOT AVAILABLE AT THIS TIME. NO VIDEO/IMAGES WERE PROVIDED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, A PATIENT DEVELOPED A BLEED. AS A RESULT OF THE BLEED, THE PATIENT RECEIVED A BLOOD TRANSFUSION AND UNDERWENT SUCTIONING. THE PATIENT SUBSEQUENTLY EXPIRED ON POST-PROCEDURE DAY #1. ALTHOUGH THE PHYSICIAN BELIEVES THE BLEED WAS LIKELY DUE TO VASCULAR/NECROTIC TISSUE THAT WAS BIOPSIED AND NO MALFUNCTION OF AN ION PRODUCT OCCURRED, IT IS UNKNOWN AS TO WHAT EXTENT (IF ANY) THE ION SYSTEM MAY HAVE CONTRIBUTED TO THE PATIENT'S DEMISE. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER COMPLETION OF AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPERIENCED DELAYED BLEEDING. ACCORDING TO THE INITIAL REPORTER, A NURSE, THERE WAS ALSO BLEEDING DURING THE CASE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE PHYSICIAN AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT WAS INITIALLY ADMITTED FOR HEMOPTYSIS PRIOR TO UNDERGOING THE ION ENDOLUMINAL LUNG BIOPSY PROCEDURE WHICH WAS PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A FORCEPS AND NEEDLE ASPIRATION BIOPSY WAS PERFORMED. THE ION ENDOLUMINAL LUNG BIOPSY PROCEDURE WAS COMPLETED. THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING ON UNSPECIFIED LUNG TISSUE. THE AMOUNT OF BLOOD LOSS WAS ESTIMATED TO BE 200 ML. MEDICAL INTERVENTION FOR THE BLEED INCLUDED A BLOOD TRANSFUSION AND SUCTIONING. THE PHYSICIAN EXPLAINED, "IT IS QUITE POSSIBLE, THE BLEEDING COULD HAVE OCCUR SPONTANEOUSLY WITHOUT BIOPSY AS HE DID BEFORE ADMISSION." THE DOCTOR REPORTED THE BLEED WAS "MORE LIKELY DUE TO VASCULAR/NECROTIC TISSUE" THAT WAS BIOPSIED AND THAT THE BLEEDING WOULD HAVE OCCURRED VIA ANOTHER MODALITY (ANY BIOPSY). PER THE PHYSICIAN, THE ION PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE BLEED. IN ADDITION, THE PHYSICIAN INDICATED THAT NO MALFUNCTION OF AN ION PRODUCT OCCURRED. THE PATIENT WAS DO NOT RESUSCITATE (DNR) AT ADMISSION AND THE FAMILY DECIDED NOT TO PURSUE FURTHER CARE POST-PROCEDURALLY. THE PATIENT WAS PLACED ON A VENTILATOR AND PROVIDED WITH COMFORT CARE. THE PATIENT EXPIRED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400501 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male ION ENDOLUMINAL SYSTEM