HF-RESECTION ELECTRODE

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE HF-RESECTION ELECTRODE "PLASMALOOP ¿ MEDIUM, 30°", LOOP, 24 FR., STANDARD, 12°-30°, FOR TCRIS (SINGLE USE), THE ELECTRODE LOOP CAME OFF THE END OF THE ELECTRODE AND STUCK INSIDE THE PATIENT¿S TISSUE (UTERUS). THE LOOP WAS SUCCESSFULLY RETRIEVED WITH FORCEPS. THE ISSUE OCCURRED DURING THE THERAPEUTIC PROCEDURE (UTERINE MYOMECTOMY BY RESECTION), THERE WAS NO DELAY AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

Additional Manufacturer Narrative

THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION: THE DEVICE WAS RETURNED AND EVALUATED, AND THE CUSTOMER¿S ALLEGATION WAS CONFIRMED; THE LOOP WAS DETACHED FROM THE FORKS ON THE DISTAL END AND WAS NOT RETURNED FOR EVALUATION. THE PROXIMAL END WAS SEVERELY BENT ON THE WHITE PORTION OF THE ELECTRODE. THE DISTAL END WAS OBSERVED UNDER A MICROSCOPE, AND THERE WAS EVIDENCE OF MELTED AND CHARRED INSULATION ON THE FORKS. ADDITIONALLY, THERE WERE SIGNS OF DRIED FOREIGN MATERIAL NEAR THE INSULATION AND THE FORKS HAD SIGNS OF EXCESSIVE BENDS AND DEFORMATION. NO FUNCTIONAL TESTS COULD BE PERFORMED AS THE PROXIMAL END WAS SEVERELY BENT AND THE LOOP WAS DETACHED. IT WAS ALSO NOTED THAT THE DEVICE WAS NOT RETURNED WITH THE HF CABLE (LOW VOLTAGE), AS WELL AS IT¿S ORIGINAL PACKAGING. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION AND CORRECTION TO D9. 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, THE ROOT CAUSE OF THE LOOSE ELECTRODE LOOP AND BURNT/MELTED DISTAL END WAS DUE TO IMPROPER HANDLING AS WELL AS EXCESSIVE FORCE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.