HF-RESECTION ELECTRODE

Additional Manufacturer Narrative

THE RESULTS OF THE INVESTIGATION ARE BASED ON THE INFORMATION PROVIDED. THE ELECTRODE SHOWS A BROKEN WIRE WITH MELTED POINTS AS WELL AS HEAT INFLUENCE AT THE WIRE ENDS AND THE INSULATING SLEEVES. IT CANNOT BE DETERMINED IF THE DAMAGE ORIGINATED IN THE BENT AREA OF THE LOOP, SINCE THERE WAS NO PHOTO OF THE WIRE FRAGMENT THAT WAS RETRIEVED FROM THE PATIENT¿S BODY. BASED ON THE DATA PRESENTLY AVAILABLE, THE CAUSE CANNOT BE DETERMINED. THE REPORTED DAMAGE CAN MOST LIKELY BE ATTRIBUTED TO THE USE OF EXCESSIVE FORCE AND/OR ANATOMICAL/PROCEDURAL COMPLICATIONS DURING THE OPERATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED AND IT WAS CONFIRMED THAT THERE WERE NO ABNORMALITIES, SPECIAL ADOPTIONS, OR VARIATIONS IN THE MANUFACTURING PROCESS.

Additional Manufacturer Narrative

THE REFERENCED HF-RESECTION ELECTRODE LOT NUMBER 1000041072 WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION. A VISUAL INSPECTION ON THE RECEIVED CONDITION NOTED THAT THE LOOP WIRE AT THE DISTAL END OF THE ELECTRODE WAS COMPLETELY BROKEN OFF AND MISSING. ADDITIONALLY, A MICROSCOPE WAS USED TO INSPECT THE BREAKAGE POINTS AND FOUND SLIGHT MELTED MARKS ON THE DISTAL TIPS OF THE BLUE AND YELLOW INSULATED POSTS. NO OTHER DAMAGE WAS NOTED. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AT THIS TIME AS THE INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

Additional Manufacturer Narrative

DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO FINDINGS AVAILABLE. THE CUSTOMER¿S COMPLAINT WAS NOT CONFIRMED. THE CAUSE COULD NOT BE DETERMINED. NO FURTHER INFORMATION WAS REPORTED.

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS DURING A HYSTEROSCOPIC FIBROID RESECTION PROCEDURE, TWO LOOP ELECTRODES THAT BROKE OFF COMPLETELY WHILE IN USE INSIDE THE UTERINE CAVITY. THE PIECES WERE RETRIEVED BY USING ANOTHER LOOP TO RECOVER THE PIECES AND/OR WERE WASHED OUT WITH FLUID. A THIRD ELECTRODE WAS USED TO COMPLETE THE INTENDED PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THIS REPORT IS FOR DEVICE ONE OF TWO.