The device was returned for investigation.Upon evaluation of the device, bending section cover crack was confirmed.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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A user facility reported to olympus that the evis exera iii gastrointestinal videoscope has a bending section cover crack.In addition, a torn seal was noted.This report is being submitted to capture the crack issue.The event occurred during reprocessing, prior to an unknown diagnostic procedure.A similar device was used to complete the procedure.There was no patient harm or user injury reported due to the event.
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This supplemental report is to inform that upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur olympus will continue to monitor complaints for this device.
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