The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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The patient was undergoing a microneurosurgery procedure to evacuate a hematoma using an artemis neuro evacuation device (artemis).During the procedure, while attempting to use the artemis within the patient, the physician noticed the artemis aspiration was weak.The physician reset the artemis to troubleshoot; however, it was unsuccessful.Therefore, the artemis was removed.The procedure was completed using a new artemis.There was no adverse effect to the patient.
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