SINGLE USE GRASPING FORCEPS FG-253SX

Description of Event or Problem

IT WAS REPORTED THAT THE GRASPING FORCEPS PACKAGE WAS DIFFICULT TO OPEN. THE TOP LAYER WAS TORN AND THE CONTENTS WERE CONTAMINATED. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. (UPDATE COMPONENT CODE FROM 4771 TO 4747 PACKAGING PROBLEM AND MEDICAL DEVICE PROBLEM CODE UPDATED FROM 4008, MATERIAL SPLIT, CUT OR TORN TO 2385, TEAR, RIP OR HOLE IN DEVICE PACKAGING.) A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE 3-DIGIT LOT NUMBER PROVIDED, THE MANUFACTURING DATE OF THE DEVICE WAS IN THE MONTH OF JULY 2023, BUT A SPECIFIC DATE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY: REPORTED EVENT HOLE OR IRREGULARITY FOUND IN SEALED STERILE PACKAGE (STERILITY COMPROMISED) WAS CAUSED DUE TO LOAD WAS FORCIBLY APPLIED TO THE STERILE PACKAGE SINCE IT WAS DIFFICULT TO OPEN THE PACKAGE. THEREFORE, THE PACKAGE WAS TORN UNINTENTIONALLY, AND THE DEVICE CONTAMINATED. REPORTED EVENT PRODUCT CONTAMINATED WAS DUE TO AN ADDITIONAL HEAT SEALING ON THE TOP OF THE STERILE PACKAGES AS CORRECTIVE AND PREVENTIVE ACTION (CAPA) CORRECTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.