BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 13666928 · Received March 4, 2022

    Report

    Report Number
    8010047-2022-03949
    Event Type
    Injury
    Date Received
    March 4, 2022
    Report Date
    March 4, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    04953170335181
    PMA / PMN Number
    K121959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED REPORT ADVERSE EVENTS AND TO PROVIDE INVESTIGATION RESULTS. NO PHYSICAL EVALUATION/INSPECTION COULD BE CONDUCTED ON THE SUSPECT DEVICE AS IT WAS NOT RETURNED TO OLYMPUS. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. OLYMPUS DOES NOT SHIP ANY DEVICE THAT DOES NOT MEET ALL DESIGN AND SAFETY SPECIFICATIONS. THERE WAS NO REPORT OF OLYMPUS DEVICE MALFUNCTION AND NO INFORMATION CONNECTING THE CAUSE OF THE REPORTED EVENTS TO THE DEVICE. FOR THESE REASONS, THE DEFINITIVE CAUSE OF THE REPORTED EVENTS COULD NOT BE DETERMINED. THIS EVENT HAS BEEN REPORTED BY THE IMPORTER ON MDR# 2951238 ¿ 2022- 00343.

    Description of Event or Problem · 0

    IT IS REPORTED IN THE LITERATURE TITLED ¿TRANSBRONCHIAL LUNG CRYOBIOPSY IS SAFE AND EFFECTIVE FOR DIAGNOSING ACUTELY ILL HOSPITALIZED PATIENTS WITH NEW DIFFUSE PARENCHYMAL LUNG DISEASE¿, PATIENTS EXPERIENCED ADVERSE EVENTS REQUIRING INTERVENTION DURING OR AFTER TRANSBRONCHIAL LUNG CRYOBIOPSY (TBLC) USING ONE OF TWO OLYMPUS SCOPES. STUDY AIM: COMPARISON OF TBLC FOR HOSPITALIZED AND OUTPATIENTS AND PROVIDE THE SAFETY AND DIAGNOSTIC YIELDS IN THESE POPULATIONS. STUDY METHOD: DEMOGRAPHIC DATA, PULMONARY FUNCTION VALUES, CHEST IMAGING PATTERN, PROCEDURAL INFORMATION, AND DIAGNOSIS WERE RECORDED FROM ENROLLED PATIENTS. COMPLICATIONS FROM THE PROCEDURE WERE THE PRIMARY OUTCOMES AND DIAGNOSTIC YIELD WAS THE SECONDARY OUTCOME. RESULTS: 77 PATIENTS (N = 22 HOSPITALIZED VS N = 55 OUTPATIENT) UNDERWENT TBLC DURING THE STUDY PERIOD. COMPARING ADVERSE EVENTS BETWEEN HOSPITALIZED AND OUTPATIENTS REVEALED NO STATISTICALLY SIGNIFICANT DIFFERENCES IN PNEUMOTHORAX (9%, N = 2 VS 5%,N = 3), TUBE THORACOSTOMY PLACEMENT (5%, N = 1 VS 2%, N = 1 ), GRADE 2 BLEEDING (9%, N = 2 VS 0%, N = 0), ESCALATION IN LEVEL OF CARE (5%, N= 1 VS 0%, N=0), 30-DAY MORTALITY (9%, N=2 VS 2%, N= 1), AND 60-DAY MORTALITY (9%, N=2 VS 4%, N=2) (P > 0.05 FOR ALL). NO DEATHS WERE ATTRIBUTED TO THE PROCEDURE. 95% OF CASES RECEIVED A MULTIDISCIPLINARY CONFERENCE DIAGNOSIS (HOSPITALIZED 100%, N=22 VS OUTPATIENTS 93%, N=51, P=0.32). CONCLUSIONS: OUR EXPERIENCE SUPPORTS THAT TBLC MAY BE A SAFE AND EFFECTIVE MODALITY FOR ACUTELY ILL-HOSPITALIZED PATIENTS WITH DPLD. FURTHER EFFORTS TO ENHANCE PROCEDURAL SAFETY AND TO DETERMINE THE IMPACT OF AN EXPEDITED TISSUE DIAGNOSIS ON PATIENT OUTCOMES ARE NEEDED. COMPLICATIONS FROM THE PROCEDURE WERE SIMILAR IN BOTH GROUPS. PNEUMOTHORAX OCCURRED IN 6% (N=5) OF PATIENTS (N= 2, 9% INPATIENT VS N= 3, 5% OUTPATIENT) (P = 0.6202). CHEST TUBE PLACEMENT WAS REQUIRED IN 3% (N=2) OF PATIENTS (N=1, 5% INPATIENT VS N=1, 2% OUTPATIENT) (P=0.4925). ALL CHEST TUBES WERE REMOVED WITHIN 24 H. GRADE 2 BLEEDING, AS PER CONSENSUS DEFINITION, OCCURRED IN 3% (N = 2) OF PATIENTS, BOTH OF WHOM WERE INPATIENTS (N=2, 9% INPATIENT), AND OF WHICH ONE, ALTHOUGH HEMODYNAMICALLY STABLE, WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR CLOSER MONITORING AS PER THE PRIMARY CARE TEAM¿S DECISION (N=1, 2% OF PATIENTS, 5% OF INPATIENTS, TRANSFER IN LEVEL OF CARE). FOR ALL OTHER PATIENTS, ONLY GRADE 1 BLEEDING OCCURRED, WHICH DID NOT REQUIRE ANY INTERVENTION ASIDE FROM BRIEF SUCTIONING WITH OBSERVATION UNTIL HEMOSTASIS WAS CONFIRMED. ALL CAUSE 30-DAY AND 60-DAY MORTALITY WERE SIMILAR BETWEEN THE TWO GROUPS AND NO DEATHS WERE DIRECTLY ATTRIBUTABLE TO THE PROCEDURE. FOR THE INPATIENT MORTALITIES, ONE PATIENT DIED TEN DAYS AFTER THE PROCEDURE, WHICH WAS ONE WEEK AFTER DISCHARGE FROM THE HOSPITAL, DUE TO OUT OF HOSPITAL CARDIAC ARREST WITH VENTRICULAR FIBRILLATION ON INITIAL HYPOXEMIC RESPIRATORY FAILURE DUE TO ARDS FROM COVID-19 PNEUMONIA 29 DAYS AFTER THE PROCEDURE. THERE WAS NO REPORT OF OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS LITERATURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE BF-1TH90 USED IN PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE BF-XT190 USED IN PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980509 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1TH190 04953170335181

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| O| R