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

Additional Manufacturer Narrative

DEVICE EVALUATION: THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION/EVALUATION BUT TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC), JAPAN (RETURNED TO OMSC ON 2021-11-10). THE EVALUATION AT OMSC CONFIRMED THAT THE LOOP WIRE AT THE DISTAL END OF THE RESECTION ELECTRODE IS BROKEN AND THE WIRE ENDS HAVE MELTED INTO BALLS. FURTHERMORE, THERE ARE BROWNISH DEPOSITS AT THE PROXIMAL END OF THE ELECTRODE AND DISTINCT TRACES ON THE ELECTRODE¿S FORK SUGGESTING THAT A SHORT CIRCUIT OCCURRED, WHICH TYPICALLY HAPPENS WHEN THE ELECTRODE COMES INTO (UNINTENDED) CONTACT WITH OTHER METAL PARTS/INSTRUMENTS WHILE THE HIGH-FREQUENCY OUTPUT IS ACTIVATED. THUS, THIS EVENT/INCIDENT WAS ATTRIBUTED TO USER ERROR. A MATERIAL OR QUALITY PROBLEM CAN BE EXCLUDED SINCE A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED LOT NUMBER OF THE RESECTION ELECTRODE WITHOUT SHOWING ANY ABNORMALITIES. THE CASE WILL BE CLOSED ON OLYMPUS SIDE WITH NO FURTHER ACTIONS. THE REPORTED EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES AND THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS.

Additional Manufacturer Narrative

THE SUSPECT MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION/INVESTIGATION. THEREFORE, THE EXACT CAUSE OF THE USER'S EXPERIENCE AND THE REPORTED PHENOMENON COULD NOT BE DETERMINED AND IS BEING JUDGED AS UNKNOWN. HOWEVER, IF THE SUSPECT MEDICAL DEVICE IS RETURNED FOR EVALUATION/INVESTIGATION OR ADDITIONAL SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem

OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSCERVICAL RESECTION OF THE ENDOMETRIUM IN SALINE (TCRIS) PROCEDURE, THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE BROKE. IT IS UNKNOWN WHETHER THE LOOP WIRE JUST BROKE OR A FRAGMENT BROKE OFF AND FELL INTO THE PATIENT¿S UTERUS. HOWEVER, AN X-RAY WAS TAKEN WHERE NO FOREIGN OBJECTS WERE FOUND INSIDE THE PATIENT¿S UTERUS. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME SET OF EQUIPMENT AND THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PATIENT INJURY. NEVERTHELESS, THIS CAUSED FEELINGS OF ANXIETY IN THE PATIENT AS SHE WAS ONLY UNDER LOCAL ANESTHESIA.