BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 11740498 · Received April 28, 2021

    Report

    Report Number
    2955842-2021-10455
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 2, 2021
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THE POST-PROCEDURE COMPLICATION MAY HAVE BEEN CAUSED BY THE PHYSICIAN INSERTING THE FLEXISION NEEDLE TOO FAR DUE TO CT-TO-BODY-DIVERGENCE, A PHENOMENON CAUSED BY DIVERGENCE BETWEEN PATIENT ANATOMY DURING THE PROCEDURE AND THE PREPROCEDURAL CT SCAN. THE PHYSICIAN ALLEGED THAT THE LESION LOCATION INDICATED BY ION DID NOT MATCH THE LESION LOCATION ON CONE-BEAM CT. THE ION USER MANUAL STATES: "USE FLUOROSCOPIC VISUALIZATION (FLUOROSCOPY) WHEN ADVANCING TOOLS PAST THE TIP OF THE CATHETER. FAILURE TO USE FLUOROSCOPY DURING BIOPSY MAY RESULT IN PATIENT HARM." SYSTEM LOG REVIEW: A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY A SENIOR FAILURE ANALYSIS ENGINEER. THE LOGS FOR SYSTEM (B)(4) WERE NOT AVAILABLE FOR THIS PROCEDURE. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED A PNEUMOTHORAX THAT REQUIRED A CHEST TUBE TO RESOLVE, DYSPNEA, AND HOSPITALIZATION FOR ONE DAY. WHEREAS THE PHYSICIAN CLAIMED THAT AN ION ISSUE WITH LESION LOCATION DISCREPANCY BETWEEN ION AND INTRAOPERATIVE CBCT OCCURRED, THE ION USER MANUAL STATES: RECOMMENDS TO "USE FLUOROSCOPIC VISUALIZATION (FLUOROSCOPY) WHEN ADVANCING TOOLS PAST THE TIP OF THE CATHETER. FAILURE TO USE FLUOROSCOPY DURING BIOPSY MAY RESULT IN PATIENT HARM."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND EXPERIENCED A PNEUMOTHORAX THAT REQUIRED A CHEST TUBE AND HOSPITALIZATION. IT WAS REPORTED THAT A 21G FLEXISION NEEDLE WAS USED TO TAKE THE BIOPSIES. ON 14-APR-2021, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE DRIVING PHYSICIAN OF THIS PROCEDURE AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE EVENT: THE PNEUMOTHORAX WAS IDENTIFIED WITH A CHEST X-RAY AFTER THE ION PROCEDURE WAS COMPLETED. WHEN ASKED IF AN ION PRODUCT CAUSED OR CONTRIBUTED TO THE PNEUMOTHORAX THE FOLLOWING ANSWER WAS PROVIDED: "THE LOCATION OF THE LESION WAS LIKELY TO BLAME, INDEPENDENT OF THE TECHNOLOGY USED." THE PHYSICIAN REPORTED THAT THE PNEUMOTHORAX WOULD HAVE "PROBABLY" OCCURRED VIA ANOTHER BIOPSY FORM. WHEN ASKED IF AN ION PRODUCT MALFUNCTION OCCURRED THE FOLLOWING ANSWER WAS PROVIDED: "THERE WAS A REGISTRATION ISSUE - THE LOCATION OF THE LESION AS DEMONSTRATED BY ION DID NOT MATCH CONEBEAM CT." IT WAS REPORTED THAT THE PNEUMOTHORAX WAS MODERATE IN SIZE AND DID NOT GROW OVER TIME. THE PATIENT EXPERIENCED DYSPNEA, WAS NEVER CONSIDERED MEDICALLY UNSTABLE, AND WAS HOSPITALIZED FOR ONE DAY DUE TO THE PNEUMOTHORAX. THE CHEST TUBE WAS PLACED TO RESOLVE THE PNEUMOTHORAX AND THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637973 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-43 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR