The customer reported to olympus, the duodenovideoscope forceps elevator became tangled with the stent, making it impossible to move.Once the scope was removed, the tangles were removed and the procedure was completed with the same set of equipment.The issue was found during a therapeutic stenting procedure.There were no reports of patient harm.
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This report is being supplemented to provide additional information based on the legal manufacturer's 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 customer reportable malfunction was most likely caused by the stress of repeated use, external factors, or handling.However, the root cause of the events could not be determined.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: the instruction manual operation manual ¿chapter 3 preparation and inspection, 3.3 inspection of the endoscope¿ describes the methods for inspection on the suggested event.Olympus will continue to monitor the field performance of this device.
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