Olympus medical systems corp.(omsc) received a literature titled "diagnostic yield and safety of cp-ebus-tbna and rp-ebus-tblb under moderate sedation: a single-center retrospective audit".This retrospective review study aimed to describe the diagnostic yield and safety of cp-ebus-tbnas and rp-ebus-tblbs when performed under moderate sedation in 421 patients.The diagnostic yield of the cp-ebus-tbnas and rp-ebus-tblbs were 62.5% and 71.6%, respectively.The most frequent diagnosis for cp-ebus-tbnas were malignancy, sarcoidosis, and mycobacterium infection (50.9%, 6.3%, and 4.2%, respectively).The most frequent diagnoses for rp-ebus - tblbs were malignancy, organizing pneumonia, and mycobacterium infection (45.8%, 10% and 3.7%, respectively) this study concludes that performing cp-ebus-tbnas and rp-ebus-tblbs under moderate sedation is safe and provides good diagnostic yield.Type of adverse events/number of patients.Bleeding - 50 patients.Pneumothorax - 1 patient.Hypoxia - 2 patients.Respiratory complaints or fever - 10 patients.This literature article requires 6 reports.The related patient identifiers are as follows: (b)(6)/na-201sx-4022.(b)(6)/bf-uc260fw.(b)(6)/fb-231d.(b)(6)/bf-q290.(b)(6)/bf-260.(b)(6)/um-s20-17s.This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.
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