This report is being supplemented to provide additional information based on the legal manufacturer's investigation and to correct information provided on the initial report.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 the suggested event was caused by handling at the user facility.In addition, it was identified that the subject device was repaired by a third-party agency.In the operation manual, section 3.8 "inspection of the endoscopic system" describes the following as precautions when it is difficult to insert accessories into the biopsy channel: - if significant resistance is encountered and insertion becomes very difficult, straighten the bending section as much as possible without losing the endoscopic image.Inserting endotherapy accessories with excessive force may damage the endoscope and/or the endotherapy accessory.In addition, the prohibition of improper repair and modification states that repairs by a third-party agency are excluded from olympus' limited warranty: - this instrument does not contain any user-serviceable parts.Do not disassemble, modify, or attempt to repair it; patient or operator injury and/or equipment damage may result.Equipment that has been disassembled, repaired, altered, changed, or modified by persons other than olympus' own authorized service personnel is excluded from olympus' limited warranty and is not warranted by olympus in any manner.
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