SINGLE USE GRASPING FORCEPS FG-253SX

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE CUSTOMER AND THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE CUSTOMER STATED THAT BEFORE OPENING, THE STERILE PACKAGE WAS INSPECTED FOR TEARS, INADEQUATE SEALING, AND WATER DAMAGE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THIS EVENT OCCURRED DURING PREPARATION FOR USE, THEREFORE THERE WAS NO IMPACT ON THE PATIENT OR PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN LESS THAN ONE YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE SUBJECT DEVICE WAS NOT RETURNED TO AOMORI OLYMPUS. THEREFORE, THE REPORTED PHENOMENON OR CONDITION OF THE DEVICE COULD NOT BE CONFIRMED. THE MANUFACTURE DATE CANNOT BE IDENTIFIED SINCE THE SUBJECT DEVICE WAS NOT RETURNED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Additional Manufacturer Narrative

TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS THAT ON THE SINGLE USE GRASPING FORCEPS FG-253SX THEY TRIED TO OPEN STERILE PACKAGING HOWEVER THE PACKAGE RIPPED/PEELED POORLY, AND THE INSIDE PRODUCT WAS CONTAMINATED DURING PREPARATION FOR USE. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.