It was reported that the camera head lens had a black image.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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The reported device, intended for use in treatment, was returned to the designated complaint unit for independent evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection of the returned device did not identify any issues.Functional evaluation revealed the device was not recognized when plugged in.The complaint has been confirmed and the root cause has been associated with an electrical component failure.Factors, unrelated to the manufacturing and design of the device that could have contributed to the reported event includes a damaged connector.A review of the device history records showed there were no indications to suggest that the lot did not meet manufacturing specification or would not be able to perform as intended.
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