SINGLE USE GRASPING FORCEPS FG-253SX

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION WITHOUT THE ORIGINAL PACKAGE WITH LOT# 41K 24 ON THE PHYSICAL DEVICE. THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE PHYSICAL DEVICE WAS INSPECTED WITH NO ISSUES. THE JAW/CLIP FROM THE DISTAL END OPENS AND CLOSES PROPERLY WHEN THE SLIDER IS MANIPULATED. THERE WERE NO EXTERNAL DAMAGES NOTED WITH THE DEVICE ITSELF. THE REPORTED COMPLAINT WAS NOT CONFIRMED DUE TO THE ORIGINAL PACKAGE WAS NOT RECEIVED TO DETERMINE THE USER'S COMPLAINT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A PACKAGING ISSUE WITH THE SUBJECT DEVICE THAT RESULTED IN AN UNSTERILE PRODUCT. THE ISSUE WAS IDENTIFIED DURING SET UP / INSPECTION FOR USE (DURING SET UP IN ROOM / BEFORE PATIENT IN ROOM). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

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