BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 22158995 · Received June 6, 2025

    Report

    Report Number
    1037905-2025-00436
    Event Type
    Injury
    Date Received
    June 6, 2025
    Date of Event
    May 9, 2025
    Report Date
    July 3, 2025
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    UDI-DI
    00827002565722
    PMA / PMN Number
    K200972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A YELLOW BIOHAZARD BAG ALONG WITH AN ADDITIONAL HEMO-7 DEVICE. PROVIDED WITH THE RETURN WAS AN OPEN POUCH FROM A FUJI POLYPECTOMY SNARE. AFFIXED TO THE FUJI POUCH WERE 2 MICRO LABELS FROM HEMO-7 LOT #S W4823704 AND W4826833 (ALLEGATION IS RELATED TO W4826833 AND W4823704 RETURNED IN ERROR). WITHOUT ADDITIONAL IDENTIFICATION OR CLARIFICATION AVAILABLE, BOTH DEVICES WERE EVALUATED. PHOTOS WERE PROVIDED AND REVIEWED. THE FIRST PHOTO SHOWS 2 DEVICES WITHIN THE FUJI POUCH WITH 1 MICRO LABEL VISIBLE (W4826833). ADDITIONALLY, THE PHOTOS TAKEN IN VIVO SHOW APPARENT POWDER AT THE BLEED SITE, HOWEVER NOT ALL THE BLOOD APPEARS TO BE COAGULATED WITH THE POWDER. OUR EVALUATION OF THE PHOTOS PROVIDED CONFIRMED THE REPORT. 1 DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN THE "ON" POSITION AND 1 WITH THE ON/OFF SWITCH IN THE "OFF" POSITION. BOTH THE RED ACTIVATION KNOBS WERE ENGAGED IN THE HANDLE INDICATING ACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. POWDER WAS OBSERVED ON THE EXTERIOR OF THE RETURNED HANDLES AND RESIDUALLY WITHIN THE DEVICE NOZZLES. THE CO2 CARTRIDGES DID NOT AUDIBLY DISCHARGE UPON DEACTIVATION AND THE CARTRIDGES WERE FULLY PUNCTURED. A VISUAL EXAMINATION OF THE O-RINGS AND LANCES INSIDE THE HANDLES SHOWED BOTH COMPONENTS TO BE POSITIONED CORRECTLY INSIDE BOTH OF THE HANDLES AND THE LANCES TO BE BEVELED. THE INSPECTION OF THE CO2 CARTRIDGES AND REGULATORS (LANCE AND O-RING) CONFIRM THE DEVICES WERE OF THE CURRENT DESIGN. THE FOAM PIECES WERE ORIENTED CORRECTLY WITHIN THE HANDLE (SLITS POINTING DOWN TOWARDS THE RED ACTIVATION KNOB). TO EVALUATE THE POWDER THE DEVICES WERE DISASSEMBLED AND THE POWDER WAS REMOVED FROM THE CHAMBERS FOR SWELL TESTING TO CONFIRM THE POWDERS ABSORPTION CAPABILITIES. THE POWDER WAS HEATED TO REMOVE AMBIENT MOISTURE AND 2 SAMPLES OF ~2G FROM EACH OF THE RETURNED DEVICES WERE ADDED TO DI WATER IN SEPARATE GRADUATED CYLINDERS, WITH THE VOLUME OF POWDER AND DI WATER TOTALING 100ML. THE POWDER SWELL WAS GREATER THAN THE MINIMUM SPECIFIED VOLUME OF 18ML/2G CONFIRMING THE POWDER'S ABSORPTION CAPABILITIES IN ALL THE TESTED SAMPLES IS ACCEPTABLE. 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. ADDITIONALLY, IQC RECORDS WERE REVIEWED FOR THE POWDER. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE RAW MATERIAL LOT. INVESTIGATION CONCLUSION: OUR EVALUATION OF THE PHOTOS PROVIDED CONFIRMED THE REPORT. HOWEVER, THE RETURNED POWDER FUNCTIONED AS INTENDED DURING OUR EVALUATION. A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. THE INSTRUCTIONS FOR USE CAUTIONS: "LIKE OTHER MODALITIES, HEMOSPRAY MAY NOT BE EFFECTIVE FOR ALL TYPES OF BLEEDS." ADDITIONALLY, THE INSTRUCTIONS FOR USE STATES, "ALLOW TIME FOR HEMOSTASIS BEFORE ASPIRATING. HEMOSTASIS MAY NOT BE IMMEDIATE BECAUSE THE POWDER TAKES TIME TO ABSORB. MULTIPLE APPLICATIONS MAY BE REQUIRED; HOWEVER NO MORE THAN (3) HEMOSPRAY DEVICES SHOULD BE APPLIED PER PATIENT." 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: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THERE HAVE BEEN NO OTHER SIMILAR OCCURRENCES REPORTED DURING THE TIME PERIOD REVIEWED. THEREFORE, THIS REPORT REPRESENTS AN ISOLATED OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC HEMOSTASIS PROCEDURE WITH BLEEDING IN THE FUNDUS, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE PHYSICIAN USED MICROTECH CLIPS FOR HEMOSTASIS, BUT THEY WERE INEFFECTIVE. AFTER ATTEMPTING EMERGENCY HEMOSTASIS WITH HEMOSPRAY, BLEEDING COULD STILL NOT BE CONTROLLED, AND THE PATIENT WAS SENT FOR SURGERY [UNABLE TO ACHIEVE HEMOSTASIS-SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT WAS SENT TO SURGERY 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
    550793 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC G56572 W4826833 00827002565722

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male ENDOSCOPE - UNKNOWN MAKE OR MODEL