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

Description of Event or Problem

IT WAS REPORTED THE HIGH FREQUENCY RESECTION ELECTRODE HAD A BENT DISTAL END WHEN IT WAS TAKEN OUT OF THE PACKAGE. THE EVENT OCCURRED DURING PREPARATION FOR USE IN A THERAPEUTIC HYSTEROSCOPIC POLYPECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR PROCEDURE DELAY.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE RESULTS OF THE DEVICE EVALUATION AND THE FINAL INVESTIGATION. FOLLOWING FIELD WAS UPDATE: D9, H2, H3, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. ACCORDING TO THE INVESTIGATION, THE DEVICE WAS NOT IN ACCORDANCE WITH THE SPECIFICATION. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, REPORTED EVENT WAS CONFIRMED IN THE VISUAL INSPECTION AND THE EVENT WAS CAUSED BY A COMPONENT FAILURE OF THE ELECTRODE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.