BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 12167903 · Received July 14, 2021

    Report

    Report Number
    2955842-2021-10783
    Event Type
    Injury
    Date Received
    July 14, 2021
    Date of Event
    June 15, 2021
    Report Date
    June 16, 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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY A FAILURE ANALYSIS ENGINEER. THE INVESTIGATION REVEALED THAT THERE WERE NO RELEVANT SYSTEM ERRORS NOTED TO HAVE OCCURRED DURING THE BIOPSY PROCEDURE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE NO PRODUCT IS EXPECTED TO BE RETURNED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. THE SYSTEM LOGS WERE PULLED FOR THE ION SYSTEM USED DURING PROCEDURE BY A SENIOR FAILURE ANALYSIS ENGINEER. HOWEVER, THE LOGS FOR SYSTEM (B)(4) ON THE DATE OF THIS PROCEDURE WERE NOT AVAILABLE. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED A PNEUMOTHORAX THAT REQUIRED A CHEST TUBE AND HOSPITALIZATION TO ASSIST IN THE PATIENT'S RECOVERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND THEN EXPERIENCED A PNEUMOTHORAX THAT REQUIRED A CHEST TUBE AND HOSPITALIZATION. THERE WAS ONE TARGET NODULE WITH A SIZE OF 0.9CM IN THE RIGHT UPPER LOBE. A FLEXISION 23G NEEDLES WAS USED TO MAKE 12 PASSES, A FORCEPS MADE 20 PASSES, AND A CYTOLOGY BRUSH MADE 3 PASSES. FOLLOW-UP: ON 23JUNE-2021, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE PHYSICIAN OF THIS PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE EVENT: THE PHYSICIAN REPORTED THERE WAS NO ION MALFUNCTION RELATED TO THIS EVENT. THE PNEUMOTHORAX WAS IDENTIFIED AFTER THE PROCEDURE AND THE PHYSICIAN DETERMINED THAT THE PATIENT REQUIRED THE CHEST TUBE TO RECOVER FROM THE PNEUMOTHORAX. THE PHYSICIAN REPORTED THAT THE PATIENT WAS ASYMPTOMATIC, AND THE PNEUMOTHORAX WAS "BIG" (NO EXACT SIZE PROVIDED). THE PATIENT WAS REPORTEDLY HOSPITALIZED OVERNIGHT. THE PHYSICIAN REPORTED THAT THE LESION WAS AT THE EDGE OF THE LUNG AND THAT THEY HAD TO TAKE "A BUNCH" OF BIOPSIES BECAUSE THEY WERE NOT GETTING A DIAGNOSIS WITH THE RAPID ON SITE EVALUATION (ROSE). THE PHYSICIAN REPORTED THAT THE PNEUMOTHORAX WAS DISCOVERED POST-OPERATION AND WAS LARGE ENOUGH TO REQUIRE A CHEST TUBE BE PLACED. THE PATIENT WAS NEVER CONSIDERED MEDICALLY UNSTABLE. THE PHYSICIAN REPORTED THAT THIS EVENT WAS NOT DUE TO ION AND THAT THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066402 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-44 N/A 00886874116234

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown ION ENDOLUMINAL SYSTEM| ION ENDOLUMINAL SYSTEM