GRASPING FORCEPS

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THE GRASPING FORCEPS HAD BURNT DEPOSITS. THE ISSUE OCCURRED DURING RECEIPT INSPECTION FOR A THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THE COMPONENT CODE HAS BEEN CORRECTED FROM JAW TO COVER. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE APPROVED FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE SUBJECT DEVICE WAS RETURNED AND EVALUATED WHERE UPON INSPECTING THE LASER-WELDED AREA AT THE DISTAL END OF THE COIL SHEATH, DISCOLORATION WAS OBSERVED DUE TO THE HEAT FROM THE LASER WELDING PROCESS. THE AREA WAS WELDED ALL AROUND AND NOT ADHERED WITH SPUTTER ACCORDING TO SPECIFICATIONS. NO SPUTTER (PARTICLE PRODUCED DURING WELDING) WAS ADHERED TO THE AREA, AND THERE WERE NO VISIBLE ABNORMALITIES IN ITS APPEARANCE. UPON COMPARING THE SUBJECT PRODUCT WITH THE AOMORI OLYMPUS INVENTORY, THE DISCOLORATION AT THE LASER-WELDED AREA WAS FOUND TO BE NEARLY IDENTICAL IN BOTH. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS DETERMINED THAT THE PRODUCT DID NOT HAVE ANY ABNORMALITIES. THE BLACK PORTION OF THE COIL SHEATH IS THE TRACE OF LASER WELDING. THIS DOES NOT AFFECT THE FUNCTIONALITY OR SAFETY OF THE PRODUCT. SINCE THE DEVICE MALFUNCTION WAS NOT CONFIRMED DURING EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.