This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Information added to the fields: h3, h6.Corrected fields: d4 (udi was inadvertently missed) a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 14 years since the subject device was manufactured.The customer's reportable malfunction was confirmed.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the defective event was caused by stress of repeated use, external factors, or handling of the device.It was confirmed that instructions, chapter 3 ¿preparation and inspection¿, section 3.2 ¿preparation and inspection of the endoscope¿ describes how to inspect for the subject events.Olympus will continue to monitor field performance for this device.
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