BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 22786906 · Received August 12, 2025

    Report

    Report Number
    1037905-2025-00582
    Event Type
    Injury
    Date Received
    August 12, 2025
    Date of Event
    July 7, 2025
    Report Date
    September 15, 2025
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    UDI-DI
    00827002565722
    PMA / PMN Number
    K200972
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. 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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. 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 (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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A CLEAR PLASTIC BAG. PROVIDED WITH THE RETURN WAS AN OPEN TRAY FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED. NOT ALL COMPONENTS WERE INCLUDED IN THE RETURN, NO CATHETERS WERE RETURNED. 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. POWDER WAS NOT OBSERVED ON THE EXTERIOR OF THE DEVICE, WITHIN THE TRAY, NOR WITHIN THE DEVICE NOZZLE. WHEN TESTED AS RETURNED THE DEVICE DID NOT SPRAY AS INTENDED. THE CO2 CARTRIDGE DID NOT AUDIBLY DISCHARGE UPON DEACTIVATION AND THE CO2 CARTRIDGE WAS FULLY PUNCTURED. A VISUAL EXAMINATION OF THE O-RING NOTED IT HAD SHIFTED, BUT DID NOT SHOW DAMAGE FROM BEING INAPPROPRIATELY POSITIONED DURING COMPRESSION, NOR WAS IT FIXED THERE, AND WAS ABLE TO BE GENTLY MOVED BACK INTO POSITION. IT IS BELIEVED THE O-RING LIKELY SHIFTED FOLLOWING/ DURING DEACTIVATION OF THE ACTIVATION KNOB. A VISUAL EXAMINATION OF LANCE INSIDE THE HANDLE SHOWED IT 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 ORIENTED CORRECTLY WITHIN THE HANDLE. WHEN TESTED WITH A NEW CO2 CARTRIDGE AND ACTIVATION KNOB, THE DEVICE SPRAYED AS INTENDED. 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. 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. CATHETER OCCLUSION CAN BE A CAUSE OF THIS DEVICE NOT BEING ABLE TO SPRAY POWDER. HOWEVER, WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE NO CATHETERS WERE RETURNED FOR EVALUATION. 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 (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 · 0

    DURING A GASTROSCOPY WITH HEMOSTASIS FOR A MALLORY-WEISS TEAR, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE HEMOSPRAY DEVICE WAS NOT WORKING, POWDER COULD NOT BE RELEASED. [UNABLE TO SPRAY SUBJECT OF REPORT]. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN SPRAYING DEVICE. 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
    2436919 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC G56572 W4762582 00827002565722

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male ENDOSCOPE - UNKNOWN MAKE OR MODEL