HEMOSPRAY ENDOSCOPIC HEMOSTAT

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 WITHOUT LID STOCK. A LOT NUMBER WAS NOT PROVIDED WITH THE RETURNED DEVICE. AN IMAGE OF THE DEVICE WITHIN THE TRAY WAS PROVIDED. THE ACTIVATION KNOB IS ENGAGED IN THE HANDLE INDICATING THE ACTIVATION OF THE CO2 CARTRIDGE. BOTH CATHETERS APPEAR TO BE IN THE TRAY BUT THEIR CONDITION IS UNABLE TO BE VISUALIZED THROUGH A TRANSLUCENT LAY OF PLASTIC. A PHOTO OF THE LOT NUMBER WAS NOT PROVIDED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED. ALL COMPONENTS WERE INCLUDED IN THE RETURN. CATHETER #1 SHOWED NO BUILD UP OF POWDER WITHIN, KINKS, NOR DISCOLORATION. A SMALL AMOUNT OF RESIDUAL POWDER WAS NOTED ON THE RED CATHETER HUB. CATHETER #2 WAS OBSERVED TO HAVE A DARKENED SECTION OF THE CATHETER NEAR THE DISTAL TIP, BUT NO KINKS WERE OBSERVED. THE DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN THE "ON" POSITION. THE RED ACTIVATION KNOB WAS ENGAGED IN THE HANDLE INDICATING ACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. SMALL AMOUNTS OF POWDER WAS OBSERVED ON THE EXTERIOR OF THE RETURNED COMPONENTS AND WITHIN THE DEVICE NOZZLE. THE DEVICE WAS UNABLE TO SPRAY AS RETURNED. THE CO2 CARTRIDGE DID NOT AUDIBLY DISCHARGE DURING DEACTIVATION AND 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. 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, THE DEVICE SPRAYED AS INTENDED BOTH WITH AND WITHOUT EITHER CATHETER ATTACHED. NO AUDIBLE LEAKAGE OF CO2 WAS OBSERVED. 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. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: THE LABORATORY EVALUATION OF THE RETURNED DEVICE COULD NOT CONFIRM THE REPORT BECAUSE THE DEVICE SPRAYED AS INTENDED WHEN TESTED WITH A NEW CO2 CARTRIDGE AND ACTIVATION KNOB. NO AUDIBLE LEAKAGE OF CO2 WAS OBSERVED. THE ROOT CAUSE FOR THE REPORT OF UNABLE TO SPRAY IS UNKNOWN. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. 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 RECORDS CONFIRMED THAT BOTH POTENTIAL LOTS 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.

Description of Event or Problem

DURING AN ENDOSCOPIC HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT UPON TURNING THE RED KNOB OF THE COMPLAINT DEVICE, A GAS LEAKING SOUND LOUDER THAN USUAL WAS HEARD. DESPITE NORMAL OPERATION AND PRESSING [THE TRIGGER] 3 TIMES (FOR APPROXIMATELY 5 SECONDS), THE POWDER FAILED TO SPRAY. IT IS SUSPECTED THAT THE GAS WAS INCOMPLETE/INSUFFICIENTLY FILLED. CONSEQUENTLY, THE PHYSICIAN OPENED A NEW DEVICE TO COMPLETE THE PROCEDURE. 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.