MICROAIRE

Additional Manufacturer Narrative

IT WAS REPORTED THAT THROUGH EXAMINATION UNDER A MICROSCOPE, MICROSCOPIC BLACK SPECKS WERE VISUALIZED IN THE POST-CARPAL TUNNEL SURGERY WOUND. IT WAS SUSPECTED THAT THE MICROSCOPIC BLACK SPECKS WERE FROM THE REPROCESSED MICROAIRE'S CARPAL TUNNEL RELEASE BLADE ASSEMBLY. PER REPORT, THESE MICROSCOPIC BLACK SPECKS WERE SUCCESSFULLY REMOVED FROM THE PATIENT THROUGH AN UNIDENTIFIED METHOD. THERE WAS NO REPORT OF PROLONGED ANESTHESIA, A SERIOUS INJURY OR ANOTHER ADVERSE PATIENT EVENT RELATED TO THE REPORTED INCIDENT. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. COMPANION SAMPLES FROM THE REPORTED LOT NUMBER WERE RETURNED AND THE REPORTED COMPLAINT IS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT MICROSCOPIC BLACK SPECKS FROM THE REPROCESSED MICROAIRE'S CARPAL TUNNEL RELEASE BLADE ASSEMBLY WERE NOTED IN THE WOUND POST CARPAL TUNNEL SURGERY.