The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.
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On july 13, 2020, olympus medical systems corp.(omsc) received literature titled "pre-use ureteroscope contamination after high level disinfection: reprocessing effectiveness and the relation with cumulative ureteroscope use".In the literature, it was reported that the result of the microbiological test using olympus endoscope and non-olympus endoscope from december 2015 to december 2017.And, in the postoperative period, the adverse events of urinary tract infection symptoms were reported in 25 of 389 procedures.It was not reported that a direct relationship between the subject device and the observed adverse events.It was reported that the subject device or other device was used with the procedure.Therefore, it was not identified which device was used for the related procedure.Therefore, omsc will submit a medical device report (mdr) for the type of adverse event of the subject device.In contrast, as a result of the microbiological testing, the following microbes were detected.Urf-v2 (2 scopes) : uropathogens (10 cfu/ml or greater).Urf-v2 (7 scopes) : skin flora (30 cfu/ml or greater).Urf-p6 (4 scopes) : skin flora (30 cfu/ml or greater).There was no other information about the infection in this literature.Based on the available information, other detailed information such as the number of microbes and serial number was not provided.Therefore, omsc will submit 13 medical device reports (mdr) depending on the number of endoscopes.This report is 14 of 14 reports.(this is a report about the microbiological testing).
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