BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 17162008 · Received June 20, 2023

    Report

    Report Number
    2955842-2023-16444
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    May 15, 2023
    Report Date
    May 26, 2023
    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
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION COULD NOT BE DETERMINED. THERE WERE NO REPORTED DEVICE ISSUES ASSOCIATED WITH THE EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER SHOWED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT EXPERIENCED HYPOXIA (REFUSED OXYGEN AT BASELINE). THE PATIENT HAD 2 LESIONS. ONE NODULE WAS 2.9CM IN SIZE IN THE RIGHT UPPER LOBE ADJACENT TO THE PLEURA, AND THE SECOND NODULE WAS 1.3CM IN SIZE AND 2CM FROM THE PLEURA. A DIAGNOSIS WAS MADE FOR BOTH LESIONS. A 23G FLEXISION NEEDLE WAS UTILIZED TO BIOPSY THE LESIONS. THE IMAGING MODALITY USED WAS C-ARM FLUOROSCOPY. STAGING UTILIZING ENDOBRONCHIAL ULTRASOUND (EBUS) WAS PERFORMED. THE PHYSICIAN REPORTED THAT THE PATIENT HAD PRE-EXISTING HYPOXIA FROM COPD AND THAT THE PATIENT HAD DECLINED OXYGEN AS AN OUTPATIENT. THE HYPOXIA WAS KNOWN PRE-PROCEDURE, BUT WORSENED POST-PROCEDURE, AND WAS IDENTIFIED WITH THE MONITORING OF VITAL SIGNS. THE PATIENT WAS OBSERVED FOR 1 NIGHT IN THE HOSPITAL. THERE WERE NO SYMPTOMS OUTSIDE OF THE EXPECTED SYMPTOMS (MILD COUGH). SUPPLEMENTAL OXYGEN (2L) WAS PROVIDED, AND MEDICAL INTERVENTIONS INCLUDED A SHORT, 3-DAY COURSE OF STEROIDS FOR QUESTIONABLE BRONCHITIS GIVEN THE PATIENT¿S SIGNIFICANT COPD. PER THE PHYSICIAN, THE HYPOXIA WAS SLIGHTLY LOWER BUT EXPECTED GIVEN THE PATIENT¿S LUNG DISEASE AND THE PROCEDURE ¿ THIS WAS DISCUSSED WITH THE PATIENT BEFORE THE PROCEDURE. PER THE REPORTER, THERE WERE NO PROCEDURE-RELATED COMPLICATIONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PHYSICIAN BELIEVED THERE WAS MAYBE A LOWER RISK FOR HYPOXIA WITH CT-GUIDED BIOPSY; HOWEVER, THE PATIENT¿S LUNG DISEASE AND THE RISK OF OTHER COMPLICATIONS, SUCH AS A PNEUMOTHORAX, MADE THE ION BIOPSY METHOD THE SAFER OPTION. THE DIAGNOSIS FOR NODULE #1 WAS ADENOCARCINOMA (MALIGNANT) AND FOR NODULE #2 WAS ADENOCARCINOMA. THE PATIENT WAS DISCHARGED HOME AND SETUP FOR HOME OXYGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458646 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female ION ENDOLUMINAL SYSTEM.