It was reported that during an arthroscopy, the werewolf flow 90 wand ablation button was sticking, and the wand kept sporadically activating itself without surgical action/control.The procedure was completed without surgical delay using a back-up device.No further complications were reported.
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H3, h6: a device deficiency was not identified, and the root cause of the reported events could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failures and/or harms were documented appropriately, and there were no indications to suggest the anticipated risks are not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.
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