SINGLE USE GRASPING FORCEPS FG-253SX

Additional Manufacturer Narrative

TO DATE, THE CUSTOMER HAVE NOT RETURNED THE DEVICE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

Description of Event or Problem

IT WAS REPORTED, THAT THE SINGLE USE GRASPING FORCEPS, WOULD TEAR A HOLE IN PACKAGING WHEN OPENING ON TO A STERILE FIELD. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT. THERE WERE NO REPORTS OF PATIENT HARM. ANOTHER RELATED COMPLAINT WAS CREATED TO COVER THE POSSIBILITY OF MORE THAN ONE EVENT UNDER (B)(6).

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, ROOT CAUSE COULD NOT BE IDENTIFIED ALTHOUGH IT CAN BE PRESUMED THAT IT WAS CAUSED ADDITIONAL HEAT SEALING ON THE TOP OF THE STERILE PACKAGING. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.