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Model Number CYF-VHA |
Device Problem
Contamination (1120)
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Patient Problems
Fever (1858); Pain (1994); Urinary Tract Infection (2120); Chills (2191); Urinary Frequency (2275)
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Event Type
Injury
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Manufacturer Narrative
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The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user¿s experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
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Event Description
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The customer reports over the last 1-2 months, a cluster of five patients have been infected with urinary tract infections after endoscopy using one of two cystoscopes that were processed in an oer-s.Case with patient identifier (b)(6) reports patient 1 of 5 -scope (cyf-vha).Case with patient identifier (b)(6) reports patient 2 of 5 -scope (cyf-vha).Case with patient identifier (b)(6) reports patient 3 of 5 -scope (cyf-vha).Case with patient identifier (b)(6) reports patient 4 of 5- scope (cyf-vha).Case with patient identifier (b)(6) reports patient 5 of 5- scope (cyf-vha).Case with patient identifier (b)(6) reports second scope processed in the oer-s (cyf-va2) (potential for cross contamination).Case with patient identifier (b)(6) reports patient infection 1 of 5 potentially related to oer-s.Case with patient identifier (b)(6) reports patient infection 2 of 5 potentially related to oer-s.Case with patient identifier (b)(6) reports patient infection 3 of 5 potentially related to oer-s.Case with patient identifier (b)(6) reports patient infection 4 of 5 potentially related to oer-s.Case with patient identifier (b)(6) reports patient infection 5 of 5 potentially related to oer-s.Case with patient identifier (b)(6) reports potential cross contamination of cyf-va2 by oer-s.Case with patient identifier (b)(6) reports the maj-891 used by the ore-s for the reprocessor.More than a year ago, there was something like green algae growing on the water filter.In view of this, the facility is concerned about infection caused by oer-s.At that time, the facility staff did not find any abnormalities after the response, so the process was completed without any problems, and there was no problem with the frequency of filter replacement at the facility noted.Microbiological investigation of the reported reprocessor indicates the oer-s is not the source of infection in the reported patients.Additional details regarding the patients and reported events have been requested.At this time, no additional information has been provided.
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Event Description
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The following additional information regarding the reported event was received: all five patients experienced fever, chills, pain when urinating, and frequent urination.The patients were prescribed antibiotics at the time of the endoscopy.Although the patients were hospitalized for fever, upon re-examination, the patients recovered and reported to be in good condition.The physician suspects the possibility of olympic equipment contributing to the infections due to the large number of patients returning with almost identical symptoms approximately ten days after each endoscopic procedure.There were no additional instruments used during the procedures.Although, additional information regarding the patients and the occurrence of disease were requested, no additional information was obtained.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been almost 8 years since the subject device was manufactured.Based on the results of the investigation, the customer performed a culture test on the scopes cyf-va2 and cyf-vha, but bacterial growth was not confirmed.Therefore, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who contact them.¿ olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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