It was reported that during an arthroscopy, the motor drive unit was not connecting.The procedure was completed with a significant delay (more than 30 minutes).It is unknown if there was a back-up device available.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Internal complaint reference case (b)(4).The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 thorough clinical assessment cannot be performed at this time since no relevant supporting clinical information has been provided.Should any additional clinical information be provided this complaint will be re-evaluated.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.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 complaint history review concluded this was a repeat issue.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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