Model Number URF-P7 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/10/2022 |
Event Type
malfunction
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Event Description
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The customer reported to olympus, the uretero-reno fiberscope tested positive for one (1) colony forming unit of unspecified aerobic bacteria.All channels were sampled.The issue was found during a routine culture of the scope.Sample was taken during reprocessing, which had occurred at the reception of the device.The scope was a brand new scope that had never been used at the hospital (had not been used on a patient yet).The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
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Manufacturer Narrative
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The olympus scope was sent to an independent laboratory for culture testing.All channels were sampled.The device tested positive for less than one (1) colony forming unit of unspecified micro-organisms.The obtained results are in conformance with the requirements.The user facility provided additional information regarding the cleaning, the disinfection and the sterilization processes performed onsite for the endoscopes.During pre-cleaning, the customer suctions water through the channels and flushes out the channels.The customer uses detergent enzymex l9.During manual cleaning, the customer brushes the operating/suction channel, suction cylinder, the operating port/opening, balloon channel and the distal end/area around the forceps channel using brushes manufactured by asept inmed.The scope is manually disinfected using anioxy.Olympus is the customer¿s maintenance company.The device has been received and the evaluation is currently in process.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was evaluated where no abnormalities were found that could have led to the positive culture.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.The following is included in the device ifu: "warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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