SYSTEM 83 PLUS WASHER/DISINFECTOR

Description of Event or Problem

ON (B)(6) 2025, WASSENBURG MEDICAL RECEIVED A CALL FROM A USER FACILITY, THE FACILITY REPRESENTATIVE STATED THAT THE FACILITY WAS REPROCESSING (2) EACH OF THE PCF-HQ190L MODELS IN EACH BAY AND WAS RECEIVING A WATER CHANNEL ERROR CONSISTENTLY IN BOTH BAYS WITHIN SEVERAL MINUTES. THE WASSENBURG MEDICAL TECHNICIAN PERFORMED TROUBLESHOOTING OF THE DEVICE WITH THE REPRESENTATIVE. THE FACILITY OPERATOR CONFIRMED AND WAS CONFIDENT THE ADAPTERS WERE ATTACHED ACCURATELY. THE WASSENBURG MEDICAL TECHNICIAN ASKED THE OPERATOR TO INITIATE A CYCLE ON BOTH BAYS. TWICE, WITHIN SEVERAL MINUTES BOTH BAYS POSTED WATER CHANNEL ERRORS. THE WASSENBURG MEDICAL TECHNICIAN ASKED THE OPERATOR TO TURN ON THE OVERRIDE SWITCH FOR BOTH BAYS WITH THE (2) EACH OF THE PCF-HQ190L MODEL TO SEE IF THE CYCLE WOULD COMPLETE. THE OVERRIDE SWITCH BYPASSES THE WATER CHANNEL ERROR IN THE HIGH-PRESSURE PORTS BUT DOES NOT CORRECT THE POTENTIAL INHERENT ISSUE (I.E. ERRATIC FLUID FLOW). ON 09/26/2025, THE LOCAL AUTHORIZED SERVICE PROVIDER, A TECHNICIAN, CONTACTED THE FACILITY REPRESENTATIVE. THE FACILITY REPRESENTATIVE INFORMED THE TECHNICIAN THAT THE FACILITY IS REPROCESSING THE PCF-HQ190L USING THE OVERRIDE SWITCH AND CYCLES HAVE COMPLETED WITHOUT ISSUE. THE FACILITY WAS INSTRUCTED TO USE THE OVERRIDE SWITCH FOR DIAGNOSTIC PURPOSE, AND THE FACILITY REPRESENTATIVE MISUNDERSTOOD THAT IT COULD BE USED AS A WORK AROUND. THE TECHNICIAN ASKED THE FACILITY REPRESENTATIVE IF WASSENBURG MEDICAL COULD SERVICE THE DEVICE AT THE FACILITY; HOWEVER, THE FACILITY REJECTED THE REQUEST. THE LABELING (OPERATORS MANUAL AND PCF-HQ190L SCOPE ADAPTATION CHART) WAS REVIEWED TO DETERMINE WHETHER IT IS APPROPRIATE TO SWITCH ON THE OVERRIDE SWITCH WHILE REPROCESSING PCF-HQ190L. UPON REVIEW, IT WAS DETERMINED THAT THERE IS NO STATEMENT IN THE LABELING DIRECTING OPERATORS TO SWITCH ON THE OVERRIDE SWITCH WHILE REPROCESSING PCF-HQ190L. AS PER CURRENT LABELING, USING SYSTEM 83 PLUS 9 WITH THE OVERRIDE SWITCH ON IS INTENDED FOR REPROCESSING OPEN ELEVATOR CHANNEL ENDOSCOPES BUT NOT FOR THE PCF-HQ190L ENDOSCOPE. THE RECURRENCE OF THE MALFUNCTION (I.E. ERRATIC FLUID FLOW) COULD LEAD TO ENDOSCOPES NOT BEING REPROCESSED PROPERLY LEADING TO SERIOUS INJURY.