It was observed that during the device inspection, the intubation fiberscope had a connecting tube that had the coating peeling (1mm2 or more).There were no reports of patient involvement.Additional details relating to the patient and the event have been requested, but no response has been received at this time.
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This supplemental report is being submitted to provide the results of 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 over 25 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the event was caused by stress from repeated use, external factors, or handling.The event can be detected by handling the device in accordance with the following instructions for use (ifu): chapter 3, preparation and inspection; 3.2, preparation and inspection of the endoscope.Olympus will continue to monitor field performance for this device.
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