AS REPORTED BY THE HOSPITAL CONTACT TO THE SALES REP, THE SURGEON INSERTED THE SIZER IN THE PATIENT'S AORTIC ANNULUS TO MEASURE AND THE SIZER BROKE IN SEVERAL PIECES WHICH FELL INTO THE PATIENT'S VENTRICLE. THE SURGEON WAS ABLE TO RECOVER THE BROKEN PIECES AND VERIFIED THAT NOTHING WAS MISSING TO THE BROKEN SIZER BY PUTTING THE PIECES TOGETHER AGAIN. THE PROCEDURE WENT WELL AND THE PATIENT RECOVERED WELL. THE SURGEON WAS SUSPECTING THAT THE SIZER WAS WORN OUT AND MAY HAVE BEEN STERILIZED TOO MANY TIMES. THE BROKEN SIZER WAS NOT KEPT, THEREFORE IT WILL NOT BE RETURNED.
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Patient 1
METHOD: DEVICE NOT RETURNED. THE SIZER IS NO LONGER AVAILABLE FOR RETURN AND EVALUATION AS IT WAS DISCARDED AT THE HOSPITAL. THEREFORE, WE ARE UNABLE TO CONFIRM THE EVENT AND TO DETERMINE ROOT CAUSE FOR THE REPORTED BREAK. THIS IS NOT A SERIALIZED DEVICE AND THERE IS NO LOT NUMBER AVAILABLE; THEREFORE, NO DEVICE HISTORY RECORD (DHR) REVIEW CAN BE DONE. THE LENGTH OF TIME THIS SIZER HAS BEEN IN USE AND THE NUMBER OF TIMES THIS DEVICE HAS BEEN CLEANED AND STERILIZED REMAINS UNKNOWN. IT IS ALSO UNKNOWN WHAT CLEANING AND STERILIZATION PARAMETERS OR ADDITIVES WERE USED ON THIS DEVICE. THIS INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED. THE SALES REP REITERATED TO THE SURGEON THAT THEY SHOULD INSPECT THE ACCESSORIES REGULARLY FOR SIGNS OF WEAR AND TEAR AND SHOULD NOT HESITATE TO REQUEST A NEW SET IF THE SIZERS ARE SHOWING SIGNS OF DETERIORATION. THIS IS ALSO MENTIONED IN EVERY OPERATING ROOM NURSE TRAINING. PER THE PRODUCT INSTRUCTIONS FOR USE (IFU) LIST TIME AND TEMPERATURE GUIDELINES AS WELL AS EQUIPMENT AND SOLUTION RECOMMENDATIONS FOR BY HAND AND BY MACHINE CLEANING AND STERILIZATION. INCLUDED IN THE IFU IS THE FOLLOWING STATEMENT: "CAUTION: EXAMINE SIZERS AND HANDLES FOR SIGNS OF WEAR, SUCH AS DULLNESS, CRACKING OR CRAZING. REPLACE SIZER/HANDLE IF ANY DETERIORATION IS OBSERVED." IT IS ASSUMED THIS EVENT OCCURRED BECAUSE THE DEVICE WAS NOT TAKEN OUT OF SERVICE WHEN INSPECTED AS RECOMMENDED BY THE IFU. HOWEVER, WITHOUT RETURN OF THE DEVICE AND/OR ANSWERS TO OUR QUESTIONS, WE ARE UNABLE TO CONCLUSIVELY DETERMINE ROOT CAUSE FOR THE FRACTURE OF THIS DEVICE. IF NEW INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.