AC 2823-01 SM JT ARTHROW,SHRT BEVEL 3

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE DEVICE WAS BEING USED FOR PULSE ABLATIVE TREATMENT DURING A RIGHT WRIST ORTHROSCOPY PROCEDURE WHEN THERMAL METAL FATIGUE WAS VISUALIZED AND WAND MATERIAL WAS NOTED TO BE SHEDDING INTO THE SURGICAL SITE. WHEN THIS WAS IDENTIFIED, A SHAVER SUCTION WAS UTILIZED AND THE WAND MATERIAL WAS REMOVED. ADDITIONAL EVALUATION VIA X-RAY IMAGING AND FLUOROSCOPY FOUND NO FURTHER WAND MATERIAL IN THE SURGICAL SITE. THE PHYSICIAN INDICATED THAT THE INCIDENT ADDED AN ADDITIONAL TEN (10) MINUTES TO THE OVERALL PROCEDURE LENGTH. A NEW DEVICE WAS SUBSEQUENTLY OBTAINED AND USED FOR THE REMAINDER OF THE PROCEDURE WITHOUT FURTHER REPORTED INCIDENT. NO ADVERSE PATIENT IMPACT WAS REPORTED. NO SAMPLE HAS BEEN EVALUATED AT THIS TIME AND A ROOT CAUSE WAS UNABLE TO BE DETERMINED. DUE TO THE REPORTED NEED FOR MEDICAL INTERVENTION TO RETRIEVE THE WAND MATERIAL FROM THE SURGICAL SITE, 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 DEVICE THERMAL METAL FATIGUE WAS VISUALIZED DURING A PROCEDURE.