SINGLE USE INJECTOR

Description of Event or Problem

THE CUSTOMER REPORTED NEEDLE COULD NOT BE INJECTED DURING A THERAPEUTIC COLONOSCOPY WITH ELECTROSURGICAL RESECTION AND SUBMUCOSAL INJECTION INVOLVING AN OLYMPUS INJECTOR AND SHEATHSET. THE PROCEDURE WAS COMPLETED USING AN OLYMPUS BACK-UP DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER.