Based on the claim against the product by the customer noting an image orientation issue, an investigation is completed to determine the cause of this reported event.The reported event was addressed with phone support.The customer replaced the endoscope to resolve the reported issue.No site visit was conducted.The system was working properly and no additional action was required as the issue was resolved.This complaint is reportable malfunction event due to the following conclusion: it was alleged that the endoscope had an image orientation issue.Poor camera control could result in unintuitive motion and subsequent tissue damage.At this time, the root cause of the failure is unknown.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
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