BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 18582169 · Received January 25, 2024

    Report

    Report Number
    1037905-2024-00048
    Event Type
    Injury
    Date Received
    January 25, 2024
    Date of Event
    December 12, 2023
    Report Date
    January 25, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. A CORRECTIVE ACTION (CAPA) WAS INITIATED TO FURTHER INVESTIGATE DEVICE FAILURE DUE TO BEING UNABLE TO SPRAY POWDER, INCLUDING CLOGGED CATHETERS. THIS DEVICE IS WITHIN THE SCOPE OF THE CAPA. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. 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

    THE FOLLOWING WAS REPORTED IN MDR 1037905-2024-00015: "IT WAS REPORTED THAT AN UNSTABLE PATIENT WITH MASSIVE BLEEDING IN THE BOWEL WAS PLACED UNDER GENERAL ANESTHESIA AND RECEIVED MANY BAGS OF BLOOD. THE PHYSICIAN USED MULTIPLE EPINEPHRINE INJECTIONS AND MULTIPLE CLIPS WITHOUT SUCCESS. THE PHYSICIAN THEN DECIDED TO TRY TO STOP THE BLEEDING ENDOSCOPICALLY. IT WAS DIFFICULT SCOPING DUE TO A LOT OF BLOOD IN THE INTESTINE, SINUOUS AND DIFFICULT BOWEL. THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT [HEMO-10] HOWEVER IT WAS REPORTED THAT PHYSICIAN USED A GASTROSCOPE WITH A WORKING CHANNEL OF 2.8 MM THAT DID NOT ALLOW THE CATHETER OF THE DEVICE TO PASS THROUGH. THE DEVICE USED (HEMO-10) MUST HAVE A WORKING CHANNEL OF 3.7MM. THEY WERE UNABLE TO USE THE DEVICE TO STOP THE BLEEDING AT THIS TIME. THE PHYSICIAN DECIDED TO USE AN UNUSED CATHETER FROM DEMONSTRATION EQUIPMENT [UNKNOWN HEMO KIT]. THE PHYSICIAN USED A GOOD DEAL OF HEMOSPRAY UNTIL THIS CATHETER FILLED WITH BLOOD. THE PATIENT WHO WAS STILL UNDER ANESTHESIA HAD TO BE MOVED DOWN TO THE OUTPATIENT CLINIC. THIS IS TO BE ABLE TO USE THE LATEST SCOPING EQUIPMENT WITH, AMONG OTHER THINGS, RDI LIGHTS. THE PATIENT WAS RESCOPED SOON AFTERWARDS. BY THEN, THE BLEEDING HAD STOPPED. THE NEXT DAY THE PATIENT WAS STABLE REGARDING HGB." THIS MDR IS BEING SENT TO CAPTURE THE CLOGGED CATHETER IN THE SECOND DEVICE USED, THE UNKNOWN HEMO-7-EU KIT. THE RELATED MDR 1037905-2024-00015 CAPTURES THE INABILITY TO ACHIEVE HEMOSTASIS DUE TO THE USE ERROR OF USING A NONCOMPATIBLE SCOPE WITH A HEMO-10-EU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016446 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GASTROSCOPE - UNKNOWN MAKE OR MODEL