It was reported that during a shoulder arthroscopy, the lens integrated system turned off and no longer works.The procedure was successfully completed with a backup device and no delay was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H3, h6: the reported device, used in treatment, was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was no relationship found between the returned device and the reported incident.The reported complaint of power loss could not be duplicated during the functional testing process.Ccu passed all functional testing and 4 hour burn-in inside of test tower.All video outputs and functions performed as expected.The complaint of power loss was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
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