Model Number CYF-5 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device was returned to olympus for evaluation.The evaluation found the objective lens and eyepiece body to have fluid invasion.The bending sheath cover glue was found to be cracked.There was a foggy stain noted on the image.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
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Event Description
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It was reported the oes cystonephrofibroscope had a c channel malfunction due to the looseness, rattling and deformation of the working channel port.No patient involvement or impact to patient care was reported.
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Manufacturer Narrative
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The supplemental report is submitted to provide the result of the legal manufacturer¿s investigation.The device history record for the subject device was reviewed and it was verified that the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation, a conclusive root cause was not identified.The investigation presumed that the biopsy port was damaged and loosened due to handling of the device.
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Search Alerts/Recalls
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