BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION

    MDR report key: 9892498 · Received March 28, 2020

    Report

    Report Number
    2955842-2020-10239
    Event Type
    Injury
    Date Received
    March 28, 2020
    Date of Event
    February 28, 2020
    Report Date
    February 28, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    PMA / PMN Number
    K182188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S POST-PROCEDURE COMPLICATION IS UNKNOWN. AT THIS TIME, THE FOLLOWING INFORMATION IS UNKNOWN: WHAT "NAVIGATION CHALLENGES" THE CLINICIAN EXPERIENCED, WHAT OTHER MODALITIES/ TECHNOLOGIES WERE USED AFTER THE ION CASE WAS ABORTED/TERMINATED, THE CAUSE OF THE PNEUMOTHORAX, THE SIZE OF THE PNEUMOTHORAX, IF THE PATIENT WAS SYMPTOMATIC, IF THE PNEUMOTHORAX GREW IN SIZE OVER TIME, AND THE PATIENT'S CURRENT STATUS. ISI HAS ATTEMPTED TO CONTACT THE CLINICIAN TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT AND REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE CLINICIAN MADE THE DECISION TO ABORT THE ION BIOPSY PROCEDURE AND PROCEEDED USING OTHER UNSPECIFIED BIOPSY MODALITIES. AT THE END OF THE PROCEDURE, A PNEUMOTHORAX WAS IDENTIFIED AND A CHEST TUBE WAS PLACED. ALTHOUGH THE ION SYSTEM WAS NOT USED TO PERFORM THE LUNG BIOPSY AND THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION PRODUCT OCCURRED, THE CAUSE OF THE PNEUMOTHORAX THAT REQUIRED MEDICAL INTERVENTION IS UNKNOWN. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN OR UNAVAILABLE. THE EXPIRATION DATE IS NOT APPLICABLE. NOT APPLICABLE BECAUSE THE PRODUCT IS NOT IMPLANTABLE. NOT AVAILABLE FOR THE SITE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT AT THE END OF AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, A PNEUMOTHORAX WAS IDENTIFIED AND A CHEST TUBE WAS REQUIRED. ON 02-MAR-2020, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI ENDOLUMINAL SALES REPRESENTATIVE (ESR) WHO WAS PRESENT DURING THE CASE AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: DUE TO INDETERMINATE NAVIGATION CHALLENGES, THE PHYSICIAN MADE THE DECISION TO ABORT THE ION CASE AND PROCEED WITH ANOTHER UNSPECIFIED MODALITY TO OBTAIN THE BIOPSY. ACCORDING TO THE ESR, THE ION SYSTEM WAS NOT USED TO PERFORM OR OBTAIN THE BIOPSY. FURTHERMORE, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE ION ENDOLUMINAL LUNG BIOPSY SYSTEM OCCURRED. PER STANDARD WORKFLOW AT THE SITE, A CONEBEAM CT-SCAN WAS PERFORMED AT THE END OF THE BIOPSY PROCEDURE USING A MODALITY OTHER THAN ION AND A POST-PROCEDURE PNEUMOTHORAX WAS IDENTIFIED. THE ESR DID NOT KNOW THE SIZE OR SEVERITY OF THE PNEUMOTHORAX. HE INDICATED THAT THE PATIENT WAS ASYMPTOMATIC AND THE HOSPITAL STAFF WAS PLANNING ON PLACING A CHEST TUBE. THE ESR DID NOT KNOW THE PATIENT'S CURRENT STATUS. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356907 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-33 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention