It was reported that during a synovectomy the full radius blade had a failure, the synovium tears up, it caused bleeding and it was relieved after using hemostasis with radiofrequency.It is unknown if there was an available back up device or a significant delay during the procedure.No other complications were reported.
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Internal complaint reference: (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 device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.Based on the information provided, the reported bleeding was relieved after using hemostasis with radiofrequency.However, it is unknown if there was an available backup device or if there was a significant delay during the procedure.Since no other complications were reported, no further clinical/medical assessment is warranted at this time.A relationship, if any, between the subject device and the reported event could not be determined.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.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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It was reported that during a synovectomy the full radius blade had a failure, the synovium tears up, it caused bleeding and it was relieved after using hemostasis with radiofrequency.Patient has been recovered.The procedure was successfully completed without a significant delay using a back-up device.No other complications were reported.
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