BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 17199852 · Received June 26, 2023

    Report

    Report Number
    1037905-2023-00311
    Event Type
    Injury
    Date Received
    June 26, 2023
    Date of Event
    May 27, 2023
    Report Date
    June 26, 2023
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    UDI-DI
    00827002565722
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510K: K200972. 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: THE ROOT CAUSE CANNOT BE CONFIRMED, HOWEVER SCOPE ADHERENCE TO TISSUE IS A KNOWN ISSUE WHEN SPRAYING HEMOSPRAY IN THE RETROFLEXED POSITION. THE IFU STATES: "WHEN SPRAYING IN RETROFLEXED POSITION, HEMOSPRAY POWDER MAY ADHERE TO THE OUTSIDE OF THE ENDOSCOPE. THIS MAY RESULT IN DIFFICULTY REPOSITIONING/REMOVING THE ENDOSCOPE, PARTICULARLY IF PASSING THROUGH A STRICTURED AREA." A CORRECTIVE ACTION HAS BEEN INITIATED TO FURTHER INVESTIGATE POWDER ADHERENCE TO THE DISTAL END OF THE SCOPE. 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 IS 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 ENDOSCOPIC PROCEDURE TO TREAT A BLEEDING ULCER IN CARDIA OF STOMACH/OGJ, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOLLOWING A HEART ATTACK AND BLEEDING ULCER. FOLLOWING ADRENALINE AND CLIPS, HEMOSPRAY APPLIED TO BLEED SITE IN RETROFLEXED POSITION (HALF A CANNISTER). THE ENDOSCOPE BECAME STUCK [SUBJECT OF REPORT] BUT WAS MOVED AFTER ONE MINUTE OF MANEUVERING THE SCOPE. UPON RESCOPING 2 DAYS LATER A LARGE AMOUNT OF SOLID HEMOSPRAY WAS OBSERVED IN THE ESOPHAGUS WHICH PREVENTED THE INSERTION OF A FEEDING TUBE. ULCER WAS HEALING WELL BUT IT WAS NOT POSSIBLE FOR ITU TO PASS AN NG TUBE DOWN. SITUATION NOW FULLY RESOLVED AND PATIENT DOING WELL. 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. PATIENT STAYED IN ITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841028 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC G56572 W4632818 00827002565722

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention OLYMPUS GASTROSCOPE