LOOP CUTTER

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 OBSERVED THAT DURING THE DEVICE INSPECTION, THE LOOP CUTTER HAD CAUGHT THE LOOP OF THE THREAD IN THE JAWS OF THE SCISSORS COULD NOT BE OPENED OR CLOSED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. ADDITIONAL INFORMATION ADDED TO FIELD D4, H3 AND H6. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT THE LOOP CUTTER HAD CAUGHT THE LOOP OF THE THREAD IN THE JAWS OF THE SCISSORS COULD NOT BE OPENED OR CLOSED WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, AND THE INFORMATION PROCEDURE THE EVENT OCCURRED POSSIBLY DUE TO AN ATTEMPT TO CUT OBJECTS OTHER THAN THE SURPLUS OF THE OLYMPUS LOOP. THIS MIGHT HAVE CAUSED THE THREAD TO GET CAUGHT IN THE CUTTER STORAGE PART WHICH RESULT, THE CUTTER COULD NOT OPEN. HOWEVER, A DEFINITIVE ROOT CAUSE OF THE EVENT COULD NOT BE IDENTIFIED. THE FOLLOWING ARE INCLUDED IN THE INSTRUCTIONS FOR USE (IFU): ·DO NOT USE THE INSTRUMENT TO CUT ANY OBJECTS OTHER THAN THE SURPLUS OF OLYMPUS LOOP (E.G., MAJ-254, MAJ-340). IF ANYTHING, OTHER THAN THE SURPLUS OF THE LOOP IS CUT, THE BLADES MAY BE DAMAGED AND UNABLE TO PERFORM PROPERLY, THE CUT OBJECT MAY BE CAUGHT IN THE TIP OF THE INSTRUMENT, AND IT MAY BECOME DIFFICULT TO SAFETY REMOVE THE INSTRUMENT FROM THE BODY. SUCH OBJECTS OTHER THAN THE SURPLUS OF LOOP MAY INCLUDE, STENT WIRE, SEWING THREADS, AND LOOP STOPPERS. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.