The device was returned, and the evaluation found no ultrasound image, missing paste-like material on forceps cover and peeling cement on pink rubber.Should additional relevant information become available, a supplemental report will be submitted.
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Correction: e2 and e3 were inadvertently omitted from the initial report.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 event was unable to be identified.The event likely occurred due to use stress, handling, or external factors.The event can be detected/prevented by following the instructions for use which state: "important information please read before use do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient." olympus will continue to monitor field performance for this device.
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