BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 9124963 · Received September 26, 2019

    Report

    Report Number
    1037905-2019-00564
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Report Date
    September 5, 2019
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    UDI-DI
    00827002565722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION REGARDING SECTION D2: SUSPECT MEDICAL DEVICE. COMMON DEVICE NAME: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. INFORMATION REGARDING SECTION G5: DEN170015. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. ALL COMPONENTS WERE NOT INCLUDED IN THE RETURN (ONLY ONE CATHETER WAS RETURNED), THEREFORE A FULL EVALUATION WAS NOT POSSIBLE. THE RETURNED CATHETER DID NOT APPEAR TO CONTAIN ANY POWDER. THE DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN THE "OFF" POSITION. THE RED ACTIVATION KNOB WAS ENGAGED IN THE HANDLE INDICATING ACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. WHEN TESTED AS RETURNED, THE DEVICE DID NOT SPRAY. THE CO2 CARTRIDGE DID NOT DISCHARGE UPON DEACTIVATION OF THE DEVICE AND 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) CONFIRMS THE DEVICE WAS OF THE CURRENT DESIGN. WHEN RETESTED WITH A NEW CO2 CARTRIDGE AND ACTIVATION KNOB, THE DEVICE DID NOT SPRAY. THE TUBES WERE DISCONNECTED FOR REMOVAL OF POWDER. NO CLUMPS OF POWDER WERE OBSERVED IN THE TUBE BETWEEN THE POWDER CHAMBER AND ON/OFF VALVE OR IN THE TUBE BETWEEN THE POWDER CHAMBER AND THE REGULATOR. A VISUAL INSPECTION OF THE CANNULA AND HOLE IN THE BOTTOM OF THE POWDER CHAMBER SHOWED THE CANNULA TO BE CLEAR. THE REGULATOR WAS TESTED WITH A NEW CO2 CARTRIDGE AND DID NOT FUNCTION AS INTENDED. CO2 WAS NOT FLOWING THROUGH THE REGULATOR. THE REGULATOR WAS DISASSEMBLED AND THE LARGE BLACK O-RING WAS PRESENT INSIDE THE REGULATOR. THE REGULATOR WAS REASSEMBLED AND RETESTED BUT DID NOT FUNCTION AS INTENDED. THE REGULATOR WAS SENT TO THE SUPPLIER FOR EVALUATION. THE SUPPLIER FUNCTIONALLY TESTED THE REGULATOR AND DID NOT ENCOUNTER ANY ISSUES. 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 ROOT CAUSE FOR REPORT OF UNABLE TO SPRAY IS UNKNOWN, THE INVESTIGATION IDENTIFIED THE REGULATOR COMPONENT AS THE LIKELY CONTRIBUTOR BUT COULD NOT ISOLATE THE SPECIFIC CAUSE. A CORRECTIVE ACTION HAS BEEN INITIATED CONCERNING DEVICE FAILURE OF 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 MANUFACTURED 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.

    Description of Event or Problem · 0

    DURING A STOMACH HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE DEVICE WOULD NOT SPRAY POWDER OUT OF THE DEVICE. THE PROCEDURE WAS COMPLETED BY CLIPPING METHOD. 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 · 1

    SUSPECT MEDICAL DEVICE. COMMON DEVICE NAME: NOT AVAILABLE REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. PMA/510K: DEN170015 A COMPONENT OF THIS PRODUCT WAS RETURNED TO THE APPROVED SUPPLIER FOR EVALUATION AND THE INVESTIGATION IS ON-GOING. ONCE ADDITIONAL INFORMATION HAS BEEN RECEIVED A FOLLOW-UP EMDR REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    DURING A STOMACH HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE DEVICE WOULD NOT SPRAY POWDER OUT OF THE DEVICE. THE PROCEDURE WAS COMPLETED BY CLIPPING METHOD. 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
    920562 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY G56572 W4118896 00827002565722

    Patients

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