BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 15047845 · Received July 18, 2022

    Report

    Report Number
    1037905-2022-00397
    Event Type
    Injury
    Date Received
    July 18, 2022
    Date of Event
    January 26, 2022
    Report Date
    July 18, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. 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. THE IFU PRECAUTIONS, "LIKE OTHER MODALITIES, HEMOSPRAY MAY NOT BE EFFECTIVE FOR ALL TYPES OF BLEEDS. GASTROINTESTINAL BLEEDING MAY EXACERBATE EXISTING COMORBIDITIES, INCREASING THE POTENTIAL FOR ADVERSE EVENTS INCLUDING PATIENT MORTALITY." PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. 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

    COOK BECAME AWARE OF THE CLINICAL LITERATURE ARTICLE INVOLVING COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE FOLLOWING ARE RELEVANT EXCERPTS: "PATIENTS FROM DEC 2011 TO APRIL 2017 FROM FACILITIES IN SINGAPORE, CANADA, UNITED KINGDOM, THE NETHERLANDS, US, AND CHINA... INITIAL HEMOSTASIS WAS ACHIEVED IN 60/66 PATIENTS (90.9%) 1 OF THESE 6 PATIENTS WERE CONVERTED TO OPEN SURGERY. THIS PATIENT DIED OF LIVER FAILURE 2 DAYS LATER (DUE TO PRE-EXISTING CONDITIONS)." THIS REPORT CAPTURES THE ONE PATIENT WHO REQUIRED SURGERY FOR HEMOSTASIS. SUNG JJY, MOREEA S, DHALIWAL H, MOFFATT DC, RAGUNATH K, PONICH T, BARKUN AN, KUIPERS EJ, BAILEY R, DONNELLAN F, WAGNER D, SANBORN K, LAU J, THE USE OF TOPICAL MINERAL POWDER AS MONOTHERAPY FOR TREATMENT OF ACTIVE PEPTIC ULCER BLEEDING, GASTROINTESTINAL ENDOSCOPY (2022), DOI:HTTPS://DOI.ORG/10.1016/J.GIE.2022.01.020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719161 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention