BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 10679700 · Received October 14, 2020

    Report

    Report Number
    1037905-2020-00436
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    September 22, 2020
    Report Date
    November 4, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    UDI-DI
    00827002210493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE SECTION COMMON DEVICE NAME: NOT AVAILABLE REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE PRODUCT CODE: QAU. INFORMATION REGARDING THE INITIAL REPORTER SECTION OCCUPATION: NON-HEALTHCARE PROFESSIONAL. INFORMATION REGARDING ALL MANUFACTURERS SECTION PMA/510(K) #: K200972 INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. ALL COMPONENTS WERE INCLUDED IN THE RETURN. 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. BOTH CATHETERS WERE RETURNED WITH THE DEVICE. NO POWDER WAS PRESENT IN EITHER CATHETER, HOWEVER BOTH HAD MINOR KINKS AND ONE CATHETER WAS BENT. WHEN TESTED AS RETURNED, THE DEVICE DID NOT SPRAY. THE DEVICE DID NOT DISCHARGE WHEN DEACTIVATED. 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 RETESTED WITH A NEW CO2 CARTRIDGE, THE DEVICE SPRAYED CONSTANTLY WITHOUT PRESSING THE ACTIVATION BUTTON. THE CATHETERS WERE ATTACHED TO THE DEVICE FOR TESTING AND SHOWN TO BE CLEAR AS THE DEVICE CONTINUED TO SPRAY CONSTANTLY. THE DEVICE WAS DISASSEMBLED AND POWDER WAS SEEN IN THE TUBES CONNECTING THE POWDER CHAMBER, ON/OFF VALVE, AND LOW PRESSURE VALVE. THE TUBES WERE DISCONNECTED FOR REMOVAL OF THE POWDER AND NO CLUMPS WERE OBSERVED. A VISUAL INSPECTION OF HOLE IN THE BOTTOM OF THE POWDER CHAMBER SHOWED IT TO BE CLEAR. THE LOW PRESSURE VALVE WAS DISSEMBLED AND EVALUATED. THE FLANGE OF THE INTERNAL PLUNGER WAS BROKEN INTO THREE PIECES. POWDER WAS OBSERVED ALONG THE INSIDE WALL OF THE VALVE, AROUND THE BASE OF THE ACTIVATION BUTTON, AND AROUND THE O-RINGS INSIDE THE VALVE. 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 UNABLE TO SPRAY IS UNKNOWN, HOWEVER THE LOW PRESSURE VALVE PLUNGER BREAKING IS THE MOST LIKELY CAUSE. A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) STATES, "DO NOT TEST DEVICE PRIOR TO INSERTION INTO ENDOSCOPE ACCESSORY CHANNEL AS THIS MAY INCREASE RISK OF CATHETER OCCLUSION." THE REPORT INDICATES THAT THE DEVICE WAS TESTED PRIOR TO USE. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTAT DEVICES 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: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED THAT THE DEVICE WAS TESTED PRIOR TO USE, 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.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. PRODUCT CODE: QAU. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. PMA/510(K) #: K200972. THE PRODUCT WAS RETURNED FOR EVALUATION AND THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT WITH PRODUCT EVALUATION INFORMATION.

    Description of Event or Problem · 1

    DURING A HEMOSTASIS PROCEDURE IN THE DUODENUM, THE PHYSICIAN SELECTED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE DEVICE WAS ACTIVATED AND AT THE MOMENT OF APPLYING THE POWDER, THE CARBON DIOXIDE (CO2) DID NOT COME OUT. 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
    1146381 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY G21049 W4231827 00827002210493

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR PENTAX EC-38I10L, COLONOSCOPE