ASC 4630-01 @TRISTAR 50 SUCTION ARTHROW&

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING AN UNIDENTIFIED PROCEDURE, A RENEWAL REPROCESSED ARTHROCARE ABLATION WAND WAS BEING USED AND THE TIP OF THE WAND BROKE OFF INSIDE OF THE PATIENT. THE REPORTING FACILITY STATES, "THE BROKEN TIP AND DEBRIS WERE SUCCESSFULLY REMOVED FROM THE PATIENT." NO INFORMATION HAS BEEN PROVIDED RELATED TO HOW THE WAND TIP OR DEBRIS WAS RETRIEVED FROM THE SURGICAL SITE. NO ADVERSE IMPACT TO THE PROCEDURE OR THE PATIENT HAS BEEN REPORTED. NO SAMPLE WAS RETURNED FOR EVALUATION. A ROOT CAUSE FOR THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED. DUE TO THE REPORTED INCIDENT, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE TIP OF A REPROCESSED ARTHROCARE ABLATION WAND FELL OFF IN THE SURGICAL SITE DURING A PROCEDURE.