HF-RESECTION ELECTRODE "PLASMALOOP ¿ MEDIUM, 30°", 24 FR., STANDARD, 12°-30°

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE (LOOP WIRE BREAKAGE) 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 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THE REPORTED LOOP WIRE BREAKAGE IS ATTRIBUTED TO INCORRECT DEVICE HANDLING AND MECHANICAL FORCE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

DURING A THERAPEUTIC TRANS CERVICAL RESECTION IN SALINE (TCRIS) PROCEDURE, THE TIP OF THE HF-RESECTION ELECTRODE BROKE WHEN IT WAS ENERGIZED AND FELL INTO THE PATIENT'S UTERUS. THE FALLEN PIECE WAS COLLECTED AND THE UTERUS WAS CLEANED. THE DOCTOR REPLACED THE DEVICE WITH ANOTHER HF-RESECTION ELECTRODE (SAME MODEL) AND COMPLETED THE SURGERY. NO PATIENT HARM WAS REPORTED.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.