Model Number CYF-VA2 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Date 07/13/2017 |
Event Type
Injury
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Manufacturer Narrative
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This device referenced in this report has been returned to olympus medical systems corp.For repair and it is under evaluation.The service record does not state that there are scratches on the wall of the channels of the subject device.At the user facility, there were 4 patients infection with pseudomonas having undergone a cystoscopy with cyf-va2 from (b)(6) in 2016.Please refer to the mdr's: #8010047-2016-01229, #8010047-2016-01230, #8010047-2016-01231 and #8010047-2016-01232.The subject device has been reportedly cleaned and disinfected after procedures, and sometimes sterilized.The manufacturing record of the device was reviewed without irregularity related to this event.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented.
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Event Description
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Olympus was informed that a hospitalized patient having undergone a cystoscopy was infected with pseudomonas after several days from the procedure.Symptoms and outcomes of the patient are unknown.The user facility is investigating if there is any patient who has symptoms of infection because the subject device has been used for other outpatient(s).As the infection source has not been identified, the user is reportedly investigating not only the subject device but other infection source.
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Manufacturer Narrative
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This device referenced in this report has been returned to olympus medical systems corp.For evaluation.During the evaluation, it was confirmed that the insertion tube was kinked, and no other anomaly was found.The exact cause could not be conclusively determined.
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Manufacturer Narrative
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This supplemental report is submitting to correct "device product code" and "pma/510(k) number".
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Search Alerts/Recalls
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