BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 18950054 · Received March 21, 2024

    Report

    Report Number
    1037905-2024-00173
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    February 25, 2024
    Report Date
    March 21, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    UDI-DI
    00827002565722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510(K): K200972. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A CLEAR PLASTIC BAG AND AN OPEN TRAY FROM LOT NUMBER: W4704133. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. ALL COMPONENTS WERE INCLUDED IN THE RETURN. CATHETER #1 WAS RETURNED INTACT WITHOUT DISCOLORATION. CATHETER #2 WAS KINKED 123.0CM FROM THE DISTAL TIP AND HAD REDDISH DISCOLORATION ON THE DISTAL TIP OF THE CATHETER. 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. LOOSE POWDER WAS PRESENT WITHIN THE TRAY AND ON ALL OF THE RETURNED COMPONENTS. THE DEVICE DID NOT SPRAY AS INTENDED AS RETURNED. THE CO2 CARTRIDGE WAS FULLY PUNCTURED. AN AUDIBLE DISCHARGE WAS NOT HEARD UPON DEACTIVATION OF THE CO2 CARTRIDGE. 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 BEGAN SPRAYING NONSTOP, WITHOUT PRESSING THE RED BUTTON, IMMEDIATELY WHEN THE SWITCH WAS TURNED TO THE "ON" POSITION. THE HANDLE WAS DISASSEMBLED, AND THE TUBES WERE DISCONNECTED FOR REMOVAL OF ANY POWDER. LOOSE POWDER WAS PRESENT IN THE FRONT TUBE CONNECTING THE ON/OFF VALVE TO THE POWDER CHAMBER. LOOSE POWDER WAS ALSO PRESENT IN THE BACK TUBE CONNECTING THE POWDER CHAMBER TO THE LOW PRESSURE VALVE. NO CLUMPS WERE FOUND IN EITHER TUBE. A VISUAL INSPECTION OF THE HOLE IN THE BOTTOM OF THE POWDER CHAMBER SHOWED IT TO BE CLEAR. 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. THIS IS THE MOST LIKELY CAUSE RESULTING IN THE VALVE REMAINING OPEN DUE TO THE POWDER. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. THE DEVICE HISTORY RECORD FOR THE LOT # 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 OF NONSTOP SPRAY. POWDER WAS OBSERVED AROUND THE O-RINGS INSIDE THE VALVE WHICH CAN CAUSE THE VALVE TO STICK AND REMAIN IN AN OPEN POSITION. IF THE VALVE IS STUCK IN AN OPEN POSITION, THE DEVICE WILL SPRAY CONTINUOUSLY. THE CAUSE OF THE POWDER WITHIN THE LOW PRESSURE VALVE 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. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. 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 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.

    Description of Event or Problem · 0

    DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT DEVICE. IT WAS REPORTED THAT [THE USER] ACTIVATED THE HANDLE AND IT IMMEDIATELY STARTED TO SPRAY OUT THE POWDER (WITHOUT HOLDING DOWN THE TRIGGER). 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
    1699909 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC W4704133 00827002565722

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SCOPE, UNKNOWN MAKE AND MODEL