BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 11752470 · Received April 30, 2021

    Report

    Report Number
    1037905-2021-00175
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 25, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    UDI-DI
    00827002210493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE SECTION. COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. PRODUCT CODE: QAU. INITIAL REPORTER OCCUPATION: UNKNOWN. INFORMATION REGARDING PMA/510(K): K200972. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. ALL COMPONENTS WERE NOT INCLUDED IN THE RETURN (NO CATHETERS WERE RETURNED), THEREFORE A COMPLETE EVALUATION WAS NOT POSSIBLE. THE DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN THE "OFF" POSITION. THE RED ACTIVATION KNOB WAS DISENGAGED IN THE HANDLE INDICATING DEACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. BLOOD WAS PRESENT ON THE NOZZLE OF THE DEVICE. THE DEVICE WAS NOT TESTED AS RETURNED DUE TO BEING PREVIOUSLY DEACTIVATED. THE CO2 CARTRIDGE WAS FULLY PUNCTURED. THE LANCE POSITION WAS MEASURED AND FOUND TO BE POSITIONED CORRECTLY. 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. WHEN TESTED WITH A NEW CO2 CARTRIDGE, THE DEVICE SPRAYED POWDER WEAKLY. THE DEVICE WAS DISASSEMBLED AND THE TUBES WERE DISCONNECTED FOR REMOVAL OF POWDER. THE TUBES CONTAINED LOOSE POWDER BUT NO HARD CLUMPS. A VISUAL INSPECTION OF HOLE IN THE BOTTOM OF THE POWDER CHAMBER SHOWED IT TO BE CLEAR. THE REGULATOR WAS TAKEN TO MANUFACTURING TO TEST THE PRESSURE SETTING USING A REGULATOR SETTING TOOL AND FOUND TO BE OPERATING AS EXPECTED. THE LOW PRESSURE VALVE WAS TAKEN TO IQC FOR TESTING ON AN ELECTRONIC LEAK TESTER AND PASSED TESTING INDICATING THAT THE VALVE WAS NOT LEAKING. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. 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 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. THE USER INDICATED THAT THE SCOPE CHANNEL MAY NOT HAVE BEEN CLEARED PRIOR TO INSERTION OF THE DEVICE WHICH COULD BE A CAUSE OF FAILURE DUE TO CLOGS IN THE CATHETER OR INTERNAL TUBING, HOWEVER OUR INVESTIGATION FINDINGS DID NOT FIND ANY CLOGS WITHIN THE DEVICE THAT WOULD INDICATE THAT THIS WAS THE CAUSE. A CORRECTIVE ACTION HAS BEEN INITIATED CONCERNING DEVICE FAILURE DUE TO BEING UNABLE TO SPRAY POWDER. 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 HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS INCLUDED IN THE SCOPE OF THIS CORRECTIVE ACTION. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. PRODUCT CODE: QAU. INITIAL REPORTER OCCUPATION: UNKNOWN. INFORMATION REGARDING PMA/510(K): K200972. THE INVESTIGATION IS CURRENT ON-GOING. A FOLLOW-UP EMDR WILL BE SENT FOLLOWING COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A HEMOSPRAY ENDOSCOPIC HEMOSTAT. HEMOSPRAY WAS USED TO TREAT AN UPPER GASTROINTESTINAL BLEED (GASTRIC BODY MASS IN STOMACH) AND AFTER SEVERAL PUFFS OF HEMOSPRAY, NO HEMOSPRAY WOULD COME OUT FROM THE APPLICATOR. TROUBLESHOOTING TECHNIQUES WERE APPLIED INCLUDING UTILIZING THE SECOND CATHETER IN THE KIT, HOWEVER, NO HEMOSPRAY WOULD COME OUT. THE USER BELIEVES BLOOD OR WATER MAY HAVE GOTTEN INTO THE APPLICATOR AND CAUSED AN INTERNAL BLOCKAGE/OCCLUSION. EVENTUALLY, A SECOND HEMOSPRAY KIT WAS OPENED AND USED TO COMPLETE THE PROCEDURE WITH FURTHER PROBLEMS. THERE WAS NO HARM TO THE PATIENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654747 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY G21049 W4401671 00827002210493

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE, UNKNOWN MAKE OR MODEL