REPORTEDLY, A CRACK WAS OBSERVED ON THE SIZERS AFTER WASHING AND STERILIZATION. IT WAS THE FIRST TIME TO USE THIS SIZER. CUSTOMER WASHED THE DEVICE WITH SPONGE AND DISHWASHING DETERGENT (MANUFACTURER: P&G) AND WASHED WITH ENZYMATIC DETERGENT FOR PROTEIN REMOVAL (MANUFACTURER: STERIS, TRADE NAME: ENZYCARE2 (1041-08, 1GAL). DEVICES WERE PUT IN THE STAINLESS BASKET AND WASHED IN THE SURGICAL INSTRUMENTS WASHER. (WASHING AT 70 DEGREES CENTIGRADE, RINSING AT 90 DEGREES CENTIGRADE AND DRYING AT 110 DEGREES CENTIGRADE. 70MINS TOTAL.) THEN REPORTEDLY, THE DEVICE WAS STERILIZED BY EOG STERILIZATION (60 DEGREES CENTIGRADE, 300MINS TOTAL). NO ADDITIONAL INFORMATION PROVIDED. DEVICE RETURNED FOR EVALUATION.
N
Patient 1
PENDING EVALUATION COMPLETION.
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Patient 1
SAFETY RISK WAS EVALUATED AND PRODUCT RISK ASSESSMENT WAS CONDUCTED. AS A RESULT OF THE RISK ASSESSMENT, CAPA WAS OPENED AND HAS ADDRESSED THIS ISSUE. THIS IS NO LONGER REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES.
D
Patient 1
THROUGH REPEATED FOLLOW UP WITH THE CUSTOMER, IT WAS LEARNED THROUGH EMAIL THAT ONE OF THE CURRENT DETERGENTS USED BY THE CUSTOMER IS NOT RECOMMENDED AS A CLEANING AGENT FOR THE MATERIAL OF THE SIZER. THE DETERGENT IS HAMO LIQUID 36. A COPY OF THE CAUTION STATEMENT WAS PROVIDED TO THE CUSTOMER. ACCORDING TO THE DETERGENTS INFORMATION ON USE: "THE USE OF DRYING/RINSING AIDS LEAVES TRACES OF SURFACTANTS ON SURFACES. THESE SURFACES, IN COMBINATION WITH STEAM STERILIZATION, CAN LEAD TO STRESS CRACKING IN CERTAIN PLASTIC STRUCTURES UNDER TENSION." THE CAUTION STATEMENT SPECIFICALLY REFERENCES PPSU (POLYPHENYLSULFONE). THIS MATERIAL IS MORE CHEMICALLY RESISTANT THAN THE POLYSULFONE USED IN THE SIZERS. THEREFORE, HAMO LIQUID 36 SHOULD NOT BE USED WITH EDWARDS SIZERS. THIS INFORMATION HAS BEEN PROVIDED TO THE CUSTOMER.
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Patient 1
EVALUATION SUMMARY ATTACHED: RECEIVED ONE SET OF SIZERS IN TRAY. SEVERAL CRACKS AND CRAZING MARKS WERE OBSERVED ON THE SIZER. THERE WERE NO VISIBLE MISSING PIECES.