BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 16960941 · Received May 19, 2023

    Report

    Report Number
    2955842-2023-13741
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    April 17, 2023
    Report Date
    May 1, 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
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. AS OF (B)(6) 2023, A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY A FAILURE ANALYSIS ENGINEER. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND EXPERIENCED EXCESSIVE BLEEDING REQUIRING UNSPECIFIED INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND EXPERIENCED EXCESSIVE BLEEDING REQUIRING UNSPECIFIED INTERVENTION. THE TARGETED NODULE WAS 2.4CM IN SIZE AND IN THE LEFT UPPER LOBE - APICOPOSTERIOR SEGMENT. INSTRUMENTS UTILIZED INCLUDED 23G FLEXISION NEEDLE, COMPATIBLE FORCEPS AND CYTOLOGY BRUSH. IMAGING MODALITIES WERE C-ARM FLUOROSCOPY, CONE BEAM, AND RADIAL ENDOBRONCHIAL ULTRASOUND (EBUS). THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. INTUITIVE SURGICAL, INC. (ISI) HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT. HOWEVER, THERE WAS NO RESPONSE RECEIVED FROM THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463936 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-60 UNKNOWN 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ION ENDOLUMINAL SYSTEM