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Model Number CYF-V2 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2023 |
Event Type
malfunction
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Event Description
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The customer reported to olympus, the videoscope had defects on the control body, including the switches, and exploded during sterilization.The cap was not on.The issue was found during reprocessing.There were no reports of patient harm.
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Manufacturer Narrative
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The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found that the dunk test failed, the device was taped and still leaking, minor chip on the distal end plastic cover, the bending section cover was blown out, there were minor control body scratches, and the bending section cover glue was chipped, and lifted.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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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.Based on the results of the investigation, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to physical damage.The event can be prevented by following the instructions for use (ifu) sections: chapter 5 reprocessing: general policy.Chapter 6 compatible reprocessing methods and chemical agents.Chapter 7 cleaning, disinfection, and sterilization procedures.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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