V-PRO

Additional Manufacturer Narrative

INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS; A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. UDI RELATED DATA CLARIFICATION: THIS EXACT CATALOG NUMBER IS NOT SOLD IN THE US; THEREFORE, THE UDI IS NOT IN GUDID.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEY OBSERVED ISSUES WITH THE SURFACE OF THEIR BRONCHOSCOPES AFTER REPROCESSING IN THEIR V-PRO MAX 2 STERILIZER. THE BRONCHOSCOPES WERE NOT AVAILABLE WHEN NEEDED RESULTING IN POSTPONED PROCEDURES. NO REPORT OF INJURY.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE STERILIZER AND FOUND IT TO BE OPERATING PROPERLY. NO ISSUES WERE NOTED WITH THE FUNCTION OR OPERATION OF THE STERILIZER. NO REPAIRS WERE REQUIRED AND THE STERILIZER WAS RETURNED TO SERVICE. A STERIS ACCOUNT MANAGER DISCUSSED THE SCOPE CLEANING AND PROCESSING PRACTICES WITH USER FACILITY PERSONNEL. THE USER FACILITY REPORTED THAT THEY ARE USING AN APPROVED DETERGENT AND PROPERLY DRY THE INSTRUMENTS PRIOR TO PROCESSING. THE ACCOUNT MANAGER LEARNED THAT ON THREE SEPARATE OCCASIONS USER FACILITY PERSONNEL SELECTED THE INCORRECT CYCLE (LUMEN CYCLE) TO STERILIZE A 11910T KARL STORZ BRONCHOSCOPE. TO DATE, THE USER FACILITY HAS NOT CONFIRMED IF THESE WERE THE SAME SCOPES SUBJECT OF THIS EVENT. BRONCHOSCOPES MAY ONLY BE PROCESSED IN THE FLEXIBLE CYCLE AS INDICATED IN THE OPERATOR MANUAL. THE OPERATOR MANUAL STATES, "FLEXIBLE CYCLE: FLEXIBLE SURGICAL ENDOSCOPES (SUCH AS THOSE USED IN ENT, UROLOGY, AND SURGICAL CARE) AND BRONCHOSCOPES MAY ONLY BE PROCESSED IN THE FLEXIBLE CYCLE." THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED; HOWEVER, INCORRECT PROCESSING CAN RESULT IN DAMAGE TO DEVICES. THE USER FACILITY REPORTED THAT THE MANUFACTURER OF THE BRONCHOSCOPES, KARL STORZ, WILL PROVIDE REPLACEMENT PRODUCT. THE STERIS ACCOUNT MANAGER COUNSELED USER FACILITY PERSONNEL ON PROPER CLEANING AND PROCESSING PRACTICES. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.