This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The customer confirmed the following information with regards to the malfunction: -the comment that it was loose meant that it was not properly attached to the scope and could easily come off.There was no damage to the tip cover.It is unclear whether the pre-use inspection was conducted to confirm that the product was installed correctly.It was also confirmed that the actual product could not be returned as it had been disposed of, and that there was a high possibility that anti-fog was not used at the facility.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 1 year since the subject device was manufactured.Based on the results of the investigation, it is likely that the dropout was caused by insufficient attachment to the scope or chemical cracks caused by adhesion of chemicals such as anti-fogging agents, resulting in insufficient fixation to the scope.However, a definitive root cause could not be established as the device was not returned for evaluation.The suggested event can be prevented by handling the device in accordance with the instructions for use which state: "place your finger in the center of the tip of the tip cover and push it straight in until the protrusion of the tip ring fits into the opening of the tip cover." "do not apply anti-fog, olive oil, or products containing petroleum-based ingredients (such as vaseline) to the tip cover or endoscope tip.Doing so may cause cracks in the tip cover." "if the tip cover cannot be attached smoothly or if you notice a mistake in the attachment procedure, remove the tip cover and use a spare tip cover to reattach the tip cover from step 1.Make sure that the tip cover is attached securely.Otherwise, the tip cover may shift or fall off.Olympus will continue to monitor field performance for this device.
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