BG DEPTH GAUGE

Additional Manufacturer Narrative

(B)(4). G2: FOREIGN - EVENT OCCURRED IN CANADA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A DEPTH GAUGE WAS FOUND BROKEN UPON RETURN OF A BORROWED INSTRUMENT TRAY. THE BREAK OCCURRED DURING THE CLEANING/WASHING PROCESS WITH NO PATIENT OR SURGEON INVOLVEMENT. THIS CAUSED NO INJURY OR DELAY TO ANY SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.