SINGLE USE GRASPING FORCEPS FG-253SX

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. UPDATED FIELDS: H6 AND H10. 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 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE FOR THE IRREGULARITY FOUND IN THE STERILE PACKAGING COULD NOT BE ESTABLISHED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE GRASPING FORCEPS FG-253SX HAD AN OUT OF BOX FAILURE WITH A FAULTY PACKAGING HAVING A TEAR, COMPROMISING THE STERILITY OF THE PACKAGE. THE ISSUE WAS FOUND DURING RECEIPT INSPECTION. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE EVALUATION FOUND THAT THERE WAS A TEAR IN THE PACKAGE, BUT THE DEVICE WAS FULLY FUNCTIONAL. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.