ARTHROCARE AMBIENT¿ SUPER TURBOVAC¿ 90° 90°SUCTION IFS 3.75 MM

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE METAL MODES OF THE REPROCESSED ARTHROCARE AMBIENT¿ SUPER TURBOVAC¿ WERE NOTED TO BE MISSING. REPORTEDLY, THE SURGICAL SITE WAS SEARCHED AND THE PATIENT'S SHOULDER WAS IRRIGATED. A C-ARM X-RAY WAS REPORTEDLY USED TO CONFIRM THAT NO METAL WAS RETAINED IN THE SHOULDER. GENERAL ANESTHESIA WAS USED AND THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCE AND NO EFFECT ON THE PATIENT'S STABILITY AS A RESULT OF THE INCIDENT. THERE WAS NO SERIOUS INJURY OR FOLLOW-UP CARE REPORTED RELATED TO THIS EVENT. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THE LOT NUMBER ASSOCIATED WITH THE DEVICE WAS NOT REPORTED. A REVIEW OF THE REPROCESSING RECORD COULD NOT BE PERFORMED. A ROOT CAUSE CANNOT BE IDENTIFIED 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 DURING A SHOULDER ARTHROSCOPY, METAL MODES OF THE REPROCESSED AMBIENT¿ SUPER TURBOVAC¿ WERE NOTED TO BE MISSING REQUIRING IRRIGATION OF THE SURGICAL SITE.