AMSCO

Additional Manufacturer Narrative

THE FDA PREMARKET SUBMISSION NUMBER LISTED IN OUR INITIAL MDR # 3005899764-2024-00038 WAS FOR THE V-PRO MAX STERILIZER. OUR FOLLOW-UP INVESTIGATION DETERMINED THAT THE REPORTED EVENT OCCURRED WITH A V-PRO MAX 2 STERILIZER, THEREFORE, THE FDA PREMARKET SUBMISSION NUMBER DOES NOT APPLY TO THIS DEVICE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR AMSCO 600 STERILIZER WAS "ALARMING" AND EMITTING A BURNING SMELL. NO REPORT OF INJURY.

Additional Manufacturer Narrative

THE INVESTIGATION INTO THE REPORTED EVENT IS IN PROCESS; A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ON-SITE TO INSPECT THE AMSCO 600 STERILIZER AND FOUND THAT THE UNIT'S CABLE ASSEMBLY WAS BURNED, AND THE PROXIMITY SENSOR WAS DAMAGED. THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED THE UNIT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS; NO ABNORMALITIES WERE NOTED. THE TECHNICIAN REPLACED THE CABLE ASSEMBLY AND PROXIMITY SENSOR, TESTED THE UNIT, CONFIRMED IT TO BE OPERATIONAL, AND RETURNED IT TO SERVICE. THE DAMAGED CABLE ASSEMBLY AND PROXIMITY SENSOR WERE RETURNED FOR FURTHER EVALUATION. ALTHOUGH INCONCLUSIVE, THE EVALUATION RESULTS DETERMINED THE POSSIBILITY OF BOTH THE CONNECTOR AND SENSOR BEING DAMAGED PRIOR TO THE EVENT. THIS MAY HAVE CAUSED THE UNIT TO SHORT CIRCUIT. IT IS UNKNOWN HOW OR WHEN THE DAMAGE OCCURRED TO THE CABLE ASSEMBLY AND PROXIMITY SENSOR. A 2-YEAR COMPLAINT REVIEW DETERMINED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

THE INFORMATION SUBMITTED UNDER MDR # 3005899764-2024-00038-02 WAS INADVERTENTLY FILED AND SHOULD HAVE BEEN SUBMITTED UNDER 3005899764-2024-00046-02.