DEXTER

Description of Event or Problem

DURING TISSUE COAGULATION IN A REFLUXSTOP¿ DEVICE IMPLANTATION PROCEDURE, IT WAS REPORTED THAT AFTER APPROXIMATELY 40 MINUTES OF USING THE MONOPOLAR HOOK, A SPARK TRAIL INDICATED A DEFECT IN THE TIP SLEEVE. THERE WAS NO HARM TO THE PATIENT. THE INSTRUMENT WAS IMMEDIATELY REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND WITHOUT INCIDENT. THERE WERE NO REPORTS OF PATIENT INJURY.

Additional Manufacturer Narrative

THE MONOPOLAR HOOK INSTRUMENT WAS RETURNED FOR ANALYSIS. INSPECTION CONFIRMED INSULATION DAMAGE IN THE TIP SLEEVE REGION; TWO HOLE WERE OBSERVED. REVIEW OF PRODUCTION RECORDS REVEALED NO MANUFACTURING ANOMALIES, AND NO EVIDENCE OF MATERIAL OR ASSEMBLY DEFECT WAS FOUND. THE FIRST HOLE WAS LIKELY CAUSED BY CONTACT WITH THE DISTAL FORK UNDER HIGH ANGULATION OR PROXIMITY TO OTHER DEVICES DURING USE. THIS DAMAGE CAN COMPROMISE INSULATION, LEADING TO SHORT CIRCUIT AND THERMAL DAMAGE WHEN ENERGIZED. THE DAMAGE IS CONSISTENT WITH MECHANICAL STRESS DURING USE; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE SECOND HOLE WAS LIKELY DAMAGED BY EXTERNAL INTERACTION. THE DAMAGED INSULATION IN CONTACT WITH TISSUE EVENTUALLY LEADS TO SHORT CIRCUIT WHEN THE TIP OF THE MONOPOLAR INSTRUMENT IS ENERGIZED.