NA

Additional Manufacturer Narrative

THROUGH FOLLOW-UP WITH USER FACILITY PERSONNEL AND A STERIS ACCOUNT MANAGER IT WAS DETERMINED THAT THE CAUSE OF THE REPORTED EVENT WAS DUE TO INCOMPATIBLE CLEANING AGENTS BEING USED ON THE TABLE PADS. USER FACILITY PERSONNEL WERE UTILIZING AN OXYCIDE DAILY DISINFECTANT CLEANER THAT CONSISTS OF HYDROGEN PEROXIDE AND PERACETIC ACID. THE CLEANING INSTRUCTIONS FOR THE MATTRESS PADS AND STERIS SURGICAL TABLE OPERATOR MANUALS STATES, "CAUTION - POSSIBLE EQUIPMENT DAMAGE: THE USE OF H2O2 + PAA (HYDROGEN PEROXIDE + PERACETIC ACID) IS STRONGLY DISCOURAGED FOR USE ON ALL STERIS PRODUCTS." USER FACILITY PERSONNEL WERE COUNSELED ON THE IMPORTANCE OF USING PROPER CLEANING AGENTS FOR THEIR TABLE PADS AND SURGICAL TABLES. 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 MEDWATCH #(B)(4) THAT THEIR SEAMS ARE COMING APART ON THEIR FOOT SECTION TABLE PAD. NO REPORT OF INJURY.