Model Number CYF-VHA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 06/22/2019 |
Event Type
Injury
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Manufacturer Narrative
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The subject device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that three patients developed fever after cystoscopy using an olympus cysto-nephro videoscope (cyf-vha or cyf-va2).First patient: the patient underwent cystoscopy using an olympus cysto-nephro videoscope (cyf-vha) on (b)(6) 2019.It was reported that the patient developed fever on (b)(6) 2019.Second patient: the patient underwent cystoscopy using an olympus cysto-nephro videoscope (cyf-vha) on (b)(6) 2019.It was reported that the patient developed fever on (b)(6) 2019.Third patient: the patient underwent cystoscopy using an olympus cysto-nephro videoscope (cyf-va2) on (b)(6) 2019.It was reported that the patient developed fever on (b)(6) 2019.The three patients¿ condition is currently unknown.The olympus cysto-nephro videoscopes (cyf-vha and cyf-va2) had been reprocessed with an olympus automated endoscope reprocessor, oer-4 (not available in the usa), using peracetic acid.It was reported that forceps/irrigation plug was not completely disassembled during reprocessing.Omsc is submitting three medical device reports according to the number of the patients.This is one of three reports.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device in this report was returned to olympus medical systems corp.(omsc) for evaluation.Omsc evaluated the subject device and confirmed as follows; the adhesive of the rubber of the bending section was peeled partially.There was resistance when a compatible instrument was inserted into/withdrawn from the instrument channel.This likely suggests that the instrument channel is damaged.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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