HF-RESECTION ELECTRODE "PLASMALOOP ¿ SMALL, 30°"

Description of Event or Problem

IT WAS REPORTED THAT DURING A "TCR" CASE, THE LOOP OF THE DEVICE BROKE AND FELL OFF INSIDE THE BODY. THE FALLEN PIECES WERE COLLECTED BY SUCTION. THE PROCEDURE WAS COMPLETED BY REPLACING IT WITH A SIMILAR DEVICE WITHOUT ANY DELAY OR HARM TO THE PATIENT.

Additional Manufacturer Narrative

D1: FULL DEVICE NAME: HF-RESECTION ELECTRODE "PLASMALOOP ¿ SMALL, 30°", SMALL LOOP, 24 FR., 12°-30°, FOR TCRIS. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S (LM) INVESTIGATION. THE DEVICE WAS EVALUATED BY OLYMPUS, AND THE REPORTED FAILURE WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 2 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED FAILURE (LOOP OF THE DEVICE BROKE/FELL INSIDE THE BODY) WAS LIKELY DUE TO WEAR AND TEAR AND/OR MISHANDLING. MOREOVER, THE LOOP AT THE DISTAL END OF THE ELECTRODE WEARS OUT DURING USE AND CAN BREAK, BURN OR MELT. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATES: "CAUTION: RISK OF INJURY TO THE PATIENT CONTACT BETWEEN THE HF-RESECTION ELECTRODE AND METAL PARTS, SUCH AS OTHER ENDOSCOPIC EQUIPMENT, IMPLANTS OR STENTS CAN RESULT IN SPARKOVER BETWEEN THE HF-RESECTION ELECTRODE AND THE METAL PART. ALWAYS KEEP A DISTANCE OF AT LEAST 10 MM BETWEEN THE HF-RESECTION ELECTRODE AND METAL PARTS." "CAUTION: RISK OF INJURY TO THE PATIENT USE EXTREME CAUTION WHEN USING ELECTROSURGERY IN CLOSE PROXIMITY TO OR IN DIRECT CONTACT WITH ANY METAL OBJECTS. DO NOT ACTIVATE THE HF-RESECTION ELECTRODE WHILE ANY PORTION OF THE HF-RESECTION ELECTRODE TIP IS IN CONTACT WITH ANOTHER METAL OBJECT. THIS CAN CAUSE UNCONTROLLED HEATING OF THE HF-RESECTION ELECTRODE AND MAY RESULT IN DAMAGE AND BREAKAGE TO THE HF-RESECTION ELECTRODE TIP. IF EXCESSIVE HEATING OR PHYSICAL FORCES CAUSE DAMAGE TO THE HF-RESECTION ELECTRODE TIP, BROKEN DEVICE FRAGMENTS MAY REMAIN IN THE BODY, POSSIBLY REQUIRING ADDITIONAL SURGERY FOR REMOVAL." THIS SUPPLEMENTAL REPORT INCLUDES AN UPDATE TO H3 FROM THE INITIAL MEDWATCH. ALSO, INFORMATION HAS BEEN ADDED TO H4. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.