SINGLE USE GRASPING FORCEPS FG-253SX

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED TO UPDATE THE LOT NUMBER AND MANUFACTURING DATE.

Additional Manufacturer Narrative

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.

Description of Event or Problem

AN OLYMPUS SENIOR SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT TWO SINGLE USE GRASPING FORCEPS FG-253SX HAD PACKAGING PROBLEMS. THE INITIAL PACKAGE WAS TOO FLIMSY / SEALED TOO TIGHTLY. IT WOULD ONLY RIP INTO TINY PIECES AND THE GRASPER BECAME CONTAMINATED AND THE SECOND GRASPER HAD THE SAME ISSUE. HOWEVER, THEY WERE ABLE TO USE IT. THE ISSUE WAS FOUND DURING A THERAPEUTIC STENT REMOVAL PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER: (B)(6).

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. DURING THE INSPECTION, OLYMPUS FOUND THE FRONT SIDE OF THE CLEAR PLASTIC ON THE PACKAGE WAS TORN/RIPPED. THERE WAS NO DAMAGES OF THE BACK SIDE OF THE DEVICE PACKAGE. THE ORIGINAL CARTON OF THE PACKAGE WAS OPENED. THE PHYSICAL DEVICE WAS ALSO INSPECTED AND THERE WERE NO SIGNS OF EXTERNAL DAMAGE OR FOREIGN RESIDUE WITH THE PHYSICAL DEVICE. 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.