GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12° AND 30° TELESCOPE

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 WIRE BROKE DURING A THERAPEUTIC BLADDER STONE PROCEDURE INVOLVING AN OLYMPUS REUSABLE RIGID ENDOSCOPIC STONE-RETRIEVAL FORCEPS. THERE WAS NO PATIENT INJURY REPORTED.