BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 18968408 · Received March 25, 2024

    Report

    Report Number
    1037905-2024-00177
    Event Type
    Injury
    Date Received
    March 25, 2024
    Date of Event
    February 29, 2024
    Report Date
    May 10, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED: SECTION G: 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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: A CORRECTIVE ACTION (CAPA) HAS BEEN INITIATED TO FURTHER INVESTIGATE POWDER ADHERENCE TO THE DISTAL END OF THE SCOPE. THIS DEVICE IS WITHIN THE SCOPE OF THE CAPA. IN ADDITION, THIS DEVICE IS CURRENTLY WITHIN THE SCOPE OF A FIELD ACTION (RES #92345) RELATED TO THE RISKS OF THE ENDOSCOPE BECOMING ADHERED TO TISSUE. THIS CUSTOMER WAS INFORMED AND ACKNOWLEDGED THESE RISKS AS PART OF THE FIELD ACTION. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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 AN UPPER GI CANCER BLEED, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS INITIALLY REPORTED THAT THE PHYSICIAN WAS SPRAYING IN THE STOMACH AND THAT IT SPRAYED THE SCOPE ALSO. ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED THE PHYSICIAN SPRAYED HEMOSPRAY PROXIMALLY THEN PUSHED FORWARD TO SPRAY DISTAL. THIS IS AGAINST THE PROTOCOL FOR USE AND PHYSICIAN WAS MADE AWARE. THE SCOPE BECAME STUCK IN THE GE JUNCTION. THEY TRIED RETRO-FLEX AND SPRAY BUT COULDN¿T GET ENOUGH WATER ON THE SCOPE. THEY FINALLY USED A BRONCH SCOPE TO FLUSH THE ENDOSCOPE FROM ABOVE WITH STANDARD WATER. THE PRODUCT WORKED AND PATIENT WAS FINISHED WITH NO COMPLICATIONS. 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
    433649 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC UNKNOWN

    Patients

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