HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THE LOOP ELECTRODE WAS BENT DURING INSPECTION FOR USE INVOLVING AN OLYMPUS HF-RESECTION ELECTRODE. THERE WAS NO PATIENT INJURY REPORTED.