BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 20914677 · Received December 12, 2024

    Report

    Report Number
    9610595-2024-40504
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    June 27, 2024
    Report Date
    December 12, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    PMA / PMN Number
    K121959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-01035. E2402 CODE SELECTED TO REPRESENT PNEUMOMEDIASTINUM. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿ADDED VALUE OF A ROBOTIC-ASSISTED BRONCHOSCOPY PLATFORM IN CONE BEAM COMPUTED TOMOGRAPHY-GUIDED BRONCHOSCOPY FOR THE DIAGNOSIS OF PULMONARY PARENCHYMAL LESIONS.¿ BACKGROUND: CONE BEAM COMPUTED TOMOGRAPHY (CBCT)-GUIDED BRONCHOSCOPIC SAMPLING OF PERIPHERAL PULMONARY LESIONS (PPLS) IS ASSOCIATED WITH SUPERIOR DIAGNOSTIC OUTCOMES. HOWEVER, THE ADDED VALUE OF A ROBOTIC-ASSISTED BRONCHOSCOPY PLATFORM IN CBCT-GUIDED DIAGNOSTIC PROCEDURES IS UNKNOWN. METHODS: WE PERFORMED A RETROSPECTIVE REVIEW OF 100 CONSECUTIVE PPLS SAMPLED USING CONVENTIONAL FLEXIBLE BRONCHOSCOPY UNDER CBCT GUIDANCE (FB-CBCT) AND 100 CONSECUTIVE PPLS SAMPLED USING AN ELECTROMAGNETIC NAVIGATION-GUIDED ROBOTIC-ASSISTED BRONCHOSCOPY PLATFORM UNDER CBCT GUIDANCE (RB-CBCT). PATIENT DEMOGRAPHICS, PPL FEATURES, PROCEDURAL CHARACTERISTICS, AND PROCEDURAL OUTCOMES WERE COMPARED BETWEEN THE 2 COHORTS. RESULTS: PATIENT AND PPL CHARACTERISTICS WERE SIMILAR BETWEEN THE FB-CBCT AND RB-CBCT COHORTS, AND THERE WERE NO SIGNIFICANT DIFFERENCES IN DIAGNOSTIC YIELD (88% VS. 90% FOR RB-CBCT, P=0.822) OR INCIDENCE OF COMPLICATIONS BETWEEN THE 2 GROUPS. AS COMPARED WITH FB-CBCT CASES, RB-CBCT CASES WERE SIGNIFICANTLY SHORTER (MEDIAN 58 MIN VS. 92 MIN, P<0.0001) AND USED SIGNIFICANTLY LESS DIAGNOSTIC RADIATION (MEDIAN DOSE AREA PRODUCT 5114 UGY.M2 VS. 8755 UGY.M2, P<0.0001). CONCLUSION: CBCT-GUIDED BRONCHOSCOPY WITH OR WITHOUT A ROBOTIC-ASSISTED BRONCHOSCOPY PLATFORM IS A SAFE AND EFFECTIVE METHOD FOR SAMPLING PPLS, ALTHOUGH THE INTEGRATION OF A ROBOTIC-ASSISTED PLATFORM WAS ASSOCIATED WITH SIGNIFICANTLY SHORTER PROCEDURE TIMES AND SIGNIFICANTLY LESS RADIATION EXPOSURE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: ·PNEUMOTHORAX, OBSERVED ONLY (1 PATIENT). ·BLEEDING, REQUIRING ESCALATION OF CARE (1 PATIENT). ·RESPIRATORY FAILURE, REQUIRING ESCALATION OF CARE (2 PATIENTS) ·CARDIAC EVENT (1 PATIENT). ·PNEUMOMEDIASTINUM WITHOUT PNEUMOTHORAX RESOLVED ON OWN (1 PATIENT). ·SEIZURE WITH HEMIPLEGIA IN POST-ANESTHESIA CARE UNIT RESOLVED SPONTANEOUSLY (1 PATIENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2204097 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-1TH190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention EDGE NAVIGATION CATHETER (MEDTRONIC)| PHILIPS AZURION CBCT SYTEM| SIEMENS ARTIS CBCT SYSTEM