IDSS INTEGRATION SYSTEM

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT AND SPOKE WITH THE USER FACILITY REGARDING THE REPORTED EVENT. USER FACILITY HAD REBOOTED THE SYSTEM AND THEN NOTED THE SYSTEM WAS DISPLAYING AN ERROR MESSAGE. AN EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. TO RESOLVE THE ISSUE, THE TECHNICIAN ADJUSTED THE SETTINGS ON THE SYSTEM. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. A 2-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE. UDI RELATED DATA CLARIFICATION - THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE; THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE CAMERA TO THEIR IDSS INTEGRATION SYSTEM DISPLAYED AN ERROR MESSAGE AND WENT BLANK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.