This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue were identified.Based on the results of the investigation, it is likely the following led to the malfunction: the suggested event occurred by application of stress such as the following: physical stress such as rubbing/hitting insertion section; chemical stress by performing reprocessing not recommended in ifu (reprocessing manual); stress by inferior storage environment (in direct sunlight, at high temperature, in high humidity, exposed to x-rays and/or ultraviolet rays, etc.).Based on the results of the investigation, it is likely the following led to the malfunction: 3.2, inspection of the endoscope: inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.Olympus will continue to monitor field performance for this device.
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