BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 19000788 · Received March 28, 2024

    Report

    Report Number
    1037905-2024-00185
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    March 5, 2024
    Report Date
    March 28, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. THERE IS NO EVIDENCE TO SUGGEST THE REPORT IS DUE TO A DEVICE FAILURE. HOWEVER, THE PATIENT/EVENT INFO - NOTES INDICATED THAT THE BOWEL WAS DISTENDED. THE IFU PRECAUTIONS "ENSURE GASTROINTESTINAL LUMEN IS NOT DISTENDED BECAUSE HEMOSPRAY ADDS VOLUME IN EXCESS OF INSUFFLATION VOLUMES DURING PROCEDURE. CLOSELY MONITOR BOWEL DISTENSION AND BALANCE INSUFFLATION AND HEMOSPRAY VOLUMES AS NECESSARY." THIS IS A LIKELY ROOT CAUSE OF THE LACERATION. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTAT ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN UNUSUAL OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED, A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. AFTER SUCCESSFUL HEMOSTASIS OF AN ULCER IN THE COLON BY USING A CLIP AND HEMOSPRAY, HEMOSPRAY WAS ALSO SPRAYED ON AN AREA NEAR THE ULCER FOR SAFETY. IN THE PROCESS, THE INTESTINAL WALL AT THIS AREA TORE AND HAD TO BE CLIPPED. FURTHER INFORMATION WAS RECEIVED: THE USER STATED THAT THE COLON WAS INSUFFLATED, DISTENDED, AND POSSIBLY THE ADDITIONAL PRESSURE OF CO2/HEMOSPRAY CAUSED THE DAMAGE OF THE ALREADY WEAKENED TISSUE. THE CATHETER WAS APPROXIMATELY 2 CM AWAY FROM THE INTESTINAL WALL WHEN THE POWDER WAS DEPLOYED, BUT THE PHYSICIAN CANNOT RULE OUT THAT THEY DID NOT TOUCH THE INTESTINAL WALL WITH THE CATHETER WHILE THERE WAS BAD SIGHT [SUBOPTIMAL VISIBILITY OF TARGET SITE] WHEN POWDER DEPLOYED. THE TEAR WAS A SEPARATE LACERATION FROM THE ULCER, BUT WAS NEAR THE ULCER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT SUSTAINED A LACERATION AND REQUIRED CLIPPING. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716711 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Female Required Intervention OLYMPUS COLONOSCOPE - UNKNOWN MODEL.