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. THE SUBJECT DEVICE WAS MANUFACTURED IN JULY 2023, BUT THE SPECIFIC DATE IS UNKNOWN. 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, THE STERILE PACKAGES THAT ARE ADDITIONALLY HEAT-SEALED HAVE A HIGHER SEAL STRENGTH THAN THOSE THAT ARE NOT ADDITIONALLY HEAT-SEALED. THEREFORE, THE STERILE PACKAGES WITH ADDITIONAL HEAT SEALING ARE DIFFICULT TO OPEN. THEREFORE, THIS MAY HAVE CAUSED THE REPORTED EVENT. CORRECTION TO D9 DEVICE RETURN DATE AND H3 DEVICE INSPECTION. THE PACKAGING FOR FG-253SX WAS RETURNED; HOWEVER, THE PHYSICAL DEVICE WAS NOT RETURNED. AN INSPECTION CANNOT BE CARRIED OUT. CORRECTION TO SECTION E FOR INFORMATION INADVERTENTLY LEFT OUT OF PREVIOUS REPORT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

THE OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT UPON OPENING THE PACKAGE TO USE, IT WOULD ONLY RIP INTO TINY PIECES AND THE GRASPER BECAME CONTAMINATED ON THE SINGLE USE GRASPING FORCEPS FG-253SX DURING THE THERAPEUTIC STENT REMOVAL PROCEDURE. THE 2ND GRASPER HAD THE SAME ISSUE; HOWEVER, THEY WERE ABLE TO USE IT. THE 2ND GRASPER HAD THE SAME PACKAGING ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THE ISSUE REPORTED DID NOT IMPACT THE OUTCOME OF THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THE REPORTED EVENT. THIS REPORT IS LINKED TO PATIENT IDENTIFIER: (B)(6).

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 OR IF ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.