HEMOSPRAY ENDOSCOPIC HEMOSTAT

Description of Event or Problem

DURING AN ENDOSCOPIC HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT DURING A ROUTINE USE OF THE DEVICE, NO PRODUCT WAS INITIALLY DISPENSED. THE CO2 CARTRIDGE DID NOT TRIGGER AND THEREFORE THE SPRAY COULD NOT BE USED. A SECOND DEVICE WAS OPENED AND FUNCTIONED AS EXPECTED. WHILE APPLYING THE SECOND DEVICE, THE TEAM CONTINUED TROUBLESHOOTING THE FIRST ONE. AFTER REPEATED MANIPULATION, INCLUDING ROTATION OF THE POWDER CHAMBER COMPONENT, THE FIRST DEVICE EVENTUALLY ACTIVATED. HOWEVER, THIS RESULTED IN DISPERSION OF THE POWDER INTO THE SURROUNDING ENVIRONMENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

Additional Manufacturer Narrative

INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A CLEAR PLASTIC BAG. PROVIDED WITH THE RETURN WAS AN OPEN TRAY FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. NOT ALL COMPONENTS WERE INCLUDED IN THE RETURN. NO CATHETERS WERE PROVIDED; THEREFORE, A COMPLETE EVALUATION WAS NOT POSSIBLE. UNIDENTIFIED PLASTIC CAPS WERE INCLUDED IN THE RETURN. POWDER WAS OBSERVED ON THE EXTERIOR OF THE DEVICE, WITHIN THE DEVICE NOZZLE, AND WITHIN THE TRAY. THE DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN THE "ON" POSITION. THE RED ACTIVATION KNOB WAS DISENGAGED IN THE HANDLE INDICATING DEACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. THE CO2 CARTRIDGE WAS FULLY PUNCTURED. A VISUAL EXAMINATION OF THE O-RING AND LANCE INSIDE THE HANDLE SHOWED BOTH COMPONENTS TO BE POSITIONED CORRECTLY INSIDE THE HANDLE AND THE LANCE TO BE BEVELED. THE INSPECTION OF THE CO2 CARTRIDGE AND REGULATOR (LANCE AND O-RING) CONFIRM THE DEVICE WAS OF THE CURRENT DESIGN. HOWEVER, IT WAS NOTED THAT THE LANCE WAS ABLE TO BE MOVED SIDE TO SIDE, THIS IS LIKELY CAUSED BY THE RELEASE OF PRESSURE DURING DEACTIVATION DAMAGING THE BACK OF THE LANCE FOLLOWING THE USER'S OBSERVED DIFFICULTY. THE FOAM WAS PRESENT AND IN THE CORRECT ORIENTATION (SLITS FACING THE RED ACTIVATION KNOB). WHEN TESTED WITH A NEW CO2 CARTRIDGE AND ACTIVATION KNOB, DUE TO THE PREVIOUSLY MENTIONED CONDITION OF THE LANCE, THE LANCE WAS UNABLE TO PIERCE THE CO2 CARTRIDGE. INSTEAD, THE LANCE WAS FOUND TO HAVE TURNED SIDEWAYS WITHIN THE REGULATOR FOLLOWING ATTEMPTED ACTIVATION. THE HANDLE WAS DISASSEMBLED. THE TUBES WERE DISCONNECTED FOR REMOVAL OF ANY POWDER. A SMALL AMOUNT OF LOOSE POWDER WITHOUT CLUMPS WAS PRESENT IN THE FRONT TUBE CONNECTING THE ON/OFF VALVE TO THE POWDER CHAMBER. A SMALL AMOUNT OF LOOSE POWDER WITHOUT CLUMPS WAS PRESENT IN THE BACK TUBE CONNECTING THE POWDER CHAMBER TO THE LOW PRESSURE VALVE. A VISUAL INSPECTION OF THE POWDER CHAMBER'S CENTER DOWNTUBE AND DIFFUSER PLATE FOUND THEM TO BE CLEAR. AN ACCUMULATION OF LOOSE POWDER WAS OBSERVED WITHIN THE POWDER CHAMBER'S CANNULA. THE LOW PRESSURE VALVE WAS DISASSEMBLED AND EVALUATED. ALL THE INTERNAL COMPONENTS WERE INTACT. HOWEVER, POWDER WAS OBSERVED WITHIN THE LOW PRESSURE VALVE ON ALL THE COMPONENTS. THE BUILDUP OF POWDER IN THE LOW PRESSURE VALVE, RESULTING IN THE VALVE EXPERIENCING DIFFICULTY WHEN OPENING AND CLOSING IS A LIKELY CAUSE FOR THE REPORTED DIFFICULTY EXPERIENCED WHEN ATTEMPTING TO SPRAY. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. NONCONFORMANCES THAT COULD POTENTIALLY BE RELATED TO THE COMPLAINT WERE CONTAINED IN THE ASSOCIATED DHR. THE NONCONFORMANCE DOCUMENTATION SUPPORTS THE AFFECTED DEVICE(S) WERE DISPOSITIONED APPROPRIATELY PRIOR TO RELEASE OF THIS LOT. THERE IS NO EVIDENCE NONCONFORMING PRODUCT WAS RELEASED FOR DISTRIBUTION. IN AN EFFORT TO HEIGHTEN AWARENESS OF THE POTENTIAL CONNECTION OF THE CUSTOMERS REPORT TO THE CURRENT MANUFACTURING PROCESSES PRODUCTION PERSONNEL WERE NOTIFIED. INVESTIGATION CONCLUSION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE ROOT CAUSE FOR REPORT OF UNABLE TO SPRAY WAS A BUILD UP OF POWDER WITHIN THE LOW PRESSURE VALVE OF THE DEVICE. THE CAUSE OF THE POWDER BUILD UP IS UNKNOWN. CATHETER OCCLUSION CAN CREATE BACKFLOW AND PUSH POWDER, BLOOD, AND FLUID BACK INTO THE DEVICE, CREATING AN INTERNAL CLOG. HOWEVER, WE COULD NOT CONDUCT A COMPLETE INVESTIGATION AS NEITHER CATHETER WAS RETURNED FOR EVALUATION. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. WHILE THE ROOT CAUSE FOR THE BUILD UP OF POWDER WITHIN THE LOW PRESSURE VALVE OF THE DEVICE IS UNKNOWN, THE ROOT CAUSE OF THE POWDER BEING RELEASED INTO THE PROCEDURE ENVIRONMENT WAS THE TROUBLESHOOTING OF THE DEVICE WHILE OUTSIDE THE ENDOSCOPE. THE INSTRUCTIONS FOR USE ADVISE: "DO NOT PRESS TRIGGER BUTTON UNTIL POWDER DEPLOYMENT IS DESIRED." ADDITIONALLY, WHEN THE DEVICE IS REMOVED FROM THE PATIENT IT IS RECOMMENDED THE ON/OFF VALVE BE IN THE "OFF" POSITION: "PRIOR TO REMOVING HEMOSPRAY DEVICE FROM PATIENT, TURN RED VALVE TO CLOSED POSITION." A CORRECTIVE ACTION (CAPA) WAS INITIATED TO FURTHER INVESTIGATE DEVICE FAILURE DUE TO BEING UNABLE TO SPRAY POWDER. THIS DEVICE IS WITHIN THE SCOPE OF THE CAPA. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A CORRECTIVE ACTION (CAPA) WAS INITIATED TO FURTHER INVESTIGATE DEVICE FAILURE DUE TO BEING UNABLE TO SPRAY POWDER. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTION. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS. ADDITIONAL COMMENTS: BASED ON THE INFORMATION PROVIDED THAT THE USER REPORTEDLY ATTEMPTED TROUBLESHOOTING THE DEVICE OUTSIDE OF THE SCOPE RESULTING IN POWDER BEING RELEASED IN THE PROCEDURE ENVIRONMENT, A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.