HF-RESECTION ELECTRODE FOR TCRIS

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER. PLEASE SEE UPDATE TO B5.

Description of Event or Problem

ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER WHICH NOTED THE REPORTED EVENT (LOOP APPEARED TO BE MELTED ON THE SIDE OF ELECTRODE) OCCURRED DURING A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WHEN THE BREAKAGE AND THE REPORTED EVENT WAS NOTED.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION, AS WELL AS CORRECTIONS TO D9 AND G2. D9: THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS THE CUSTOMER CONFIRMED THAT THE DEVICE WAS MISPLACED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT¿S LIKELY THE REPORTED EVENT (LOOP APPEARED TO BE MELTED ON THE SIDE OF ELECTRODE) WAS DUE TO WEAR AND TEAR. THE ROOT CAUSE OF THIS EVENT WAS UNABLE TO BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

AS REPORTED, "SURGEON WAS USING A RESECTOSCOPE WITH A LOOP ELECTRODE IN THE UTERUS. AT THE END OF THE CASE (UNSPECIFIED PROCEDURE) THE LOOP WAS REMOVED FROM THE UTERUS AND IT WAS NOTED THAT THE LOOP ELECTRODE WAS SPLIT AND VISUALLY IT APPEARED THAT THE LOOP HAD MELTED ON ONE SIDE OF THE ELECTRODE". THERE WAS NO PATIENT HARM , NO ADVERSE EVENT REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

Additional Manufacturer Narrative

THE SUBJECT DEVICE WAS RECEIVED AT SERVICE BUSINESS CENTER FOR EVALUATION, HOWEVER, THE EVALUATION IS STILL PENDING. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.