SINGLE USE GRASPING FORCEPS FG-253SX

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE DISPOSABLE GRASPING FORCEPS TORE A HOLE IN THE PACKAGING WHEN OPENING IN A STERILE FIELD. THERE WAS A FEW OF THE GRASPERS BEING PREPPED THAN THE ONE PACKAGE INVOLVED. THE ISSUE OCCURRED DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTED FIELDS: H8 ADDITIONAL INFORMATION ADDED TO FIELD B5, D8, E2, E3, G2, H3 AND H6. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE CUSTOMER'S ALLEGATION OF HOLE OR IRREGULARITY FOUND IN SEALED STERILE PACKAGE (STERILITY COMPROMISED) WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE EVENT OCCURRED DUE TO ADDITIONAL HEAT SEALING ON THE TOP OF THE STERILE PACKAGES. THE FIRST HEAT-SEALED SECTION IS IN THE SHAPE OF A MOUNTAIN. ADDITIONAL HEAT SEAL IS LINEAR AND APPLIED AT THE TOP OF THE MOUNTAIN AT THE FIRST HEAT-SEALED SECTION. THEREFORE, IT IS SHORT FROM THE EDGE OF THE PACKAGE TO THE HEAT-SEALED SECTION. THE PACKAGES WITH ADDITIONAL HEAT SEALING HAVE A HIGHER SEAL STRENGTH THAN THOSE WITHOUT ADDITIONAL HEAT SEALING. THEREFORE, THE PACKAGE IS DIFFICULT TO OPEN. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

THE ISSUE WAS FOUND DURING PREPARATION FOR A THERAPEUTIC CYSTOSCOPY PROCEDURE.