SINGLE USE GRASPING FORCEPS FG-253SX

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THE GRASPING FORCEP'S PACKAGING WAS POOR, AND THE CLEAR FILM FREQUENTLY TORE, COMPROMISING STERILITY. THE ISSUE OCCURRED DURING PREPARATION OF USE OF A THERAPEUTIC CYSTO STENT REMOVAL PROCEDURE. THE INTENDED PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H4 - THE MANUFACTURE DATE WAS ISOLATED TO MARCH OF 2024; HOWEVER, THE EXACT DATE WAS UNKNOWN. STATING 01 MARCH IN H4 IS A PLACEHOLDER AND IS NOT INDICATIVE OF A KNOWN EXACT DATE. 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, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE SUGGESTED PHENOMENON WAS PRESUMED TO HAVE BEEN DUE TO ADDITIONAL HEAT SEALING ON THE TOP OF THE STERILE PACKAGES. AS THERE WAS NO INFORMATION RECEIVED OF CLEAR MISUSE OF THE DEVICE, THERE IS NO LABELING ADVISORY THAT WAS DEEMED REQUIRED OR RECOMMENDED FOR THE USER FACILITY. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.