The suspect device was sent to an olympus service center for evaluation.Inspection and testing did not confirm the reported event.Service found the bending section was broken due to physical stress and there was an air leak due to the bending section being damaged.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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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, it is likely that the bending section was damaged.However, a definitive root cause of the damage could not be determined.The following is included in the instructions for use (ifu) and may have helped prevent the event: "never perform angulation control forcibly or abruptly.Never forcefully pull, twist or rotate the angulated bending section.Patient injury, bleeding, and/or perforation can result.It may also become impossible to straighten the bending section during an examination." olympus will continue to monitor field performance for this device.
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