VERIFY RESI-TEST SLIDE-THRU

Additional Manufacturer Narrative

THE DEVICES SUBJECT OF THE REPORTED EVENT WERE NOT RETURNED TO STERIS FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICES, AN EVALUATION COULD NOT BE COMPLETED, AND THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. STERIS EVALUATED THE REPORTED EVENT AND DETERMINED IT DOES NOT MEET OUR REPORTING CRITERIA UNDER 21 CFR PART 803. IT SHOULD BE NOTED THAT STERIS IS SUBMITTING A MEDICAL DEVICE REPORT (MDR) SOLELY DUE TO THE RECEIPT OF THE USER FACILITY MEDWATCH REPORT WHICH IS IN ACCORDANCE WITH OUR PROCEDURES AND POLICIES. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED VIA (B)(4), THAT "IT WAS DISCOVERED WHILE REPROCESSING AN ENDOSCOPE THE RESI TEST BRUSH WAS SHREDDING WHEN BEING PLACED THROUGH THE SCOPE." NO REPORT OF INJURY.