Model Number CYF-5A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Inflammation (1932)
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Event Date 09/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc will start evaluating the device.There were no further details provided.If significant additional information is received, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that five patients developed cystitis after procedures using this product.The device had been reprocessed by an non-olympus automated reprocessing machine espal.According to the user facility, the manufacturer has confirmed the reprocessing machine has no problem.Therefore, the user facility suspects that the olympus endoscope caused the patient infections and contacted olympus to ask for investigation.A total of five reports are being submitted for the five patients.This is the 1st of 5 reports.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The evaluation of the subject device by olympus medical systems corp.(omsc) confirmed following: the device passed the leakage testing.Some residues remained on the light guide lens, the objective lens and the distal end of the instrument channel.The residue on the distal end of the instrument channel could be easily scrubbed off.It is considered that the remained residues caused due to insufficient reprocessing.Omsc reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, it is unlikely that the reported event occurred due to the scope, because there was no damage that may result in insufficient reprocessing.
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Search Alerts/Recalls
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