The device was returned for investigation.Upon evaluation of the device, the gas cylinder connection on the front panel was deformed.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
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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, and since the stripped nut has been confirmed, the pneumoperitoneum tube (co2 gas inlet) could not be connected.However, the root cause cannot be specified.Olympus will continue to monitor field performance for this device.
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