It was reported that during a shoulder arthroscopy the camera head went black.The procedure was successfully completed with a backup device, no delay 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.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issues were observed.A functional evaluation did not reveal any problems.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.A complaint history review found related failures.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.
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