BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 19990661 · Received August 15, 2024

    Report

    Report Number
    1037905-2024-00463
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 20, 2024
    Report Date
    September 20, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    UDI-DI
    00827002246638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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. 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: 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. 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.

    Additional Manufacturer Narrative · 0

    CONTINUED: SECTION G: 510K: K200972. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A YELLOW BIOHAZARD BAG, PROVIDED WITH THE RETURN WAS AN OPEN TRAY FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED. NOT ALL COMPONENTS WERE INCLUDED IN THE RETURN (NO CATHETERS WERE RETURNED), THEREFORE A COMPLETE EVALUATION WAS NOT POSSIBLE. THE DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN THE "OFF" POSITION. THE RED ACTIVATION KNOB WAS ENGAGED IN THE HANDLE INDICATING ACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. POWDER WAS NOT OBSERVED ON THE EXTERIOR OR WITHIN THE TRAY. RESIDUAL POWDER WAS OBSERVED WITHIN THE DEVICE NOZZLE. THE DEVICE DID NOT SPRAY AS RETURNED. THE CO2 CARTRIDGE DID NOT AUDIBLY DISCHARGE UPON DEACTIVATION. THE CO2 CARTRIDGE WAS FULLY PUNCTURED. A VISUAL EXAMINATION OF THE O-RING AND LANCE INSIDE THE HANDLE SHOWED BOTH COMPONENTS TO BE POSITIONED CORRECTLY INSIDE THE HANDLE AND THE LANCE TO BE BEVELED. THE INSPECTION OF THE CO2 CARTRIDGE AND REGULATOR (LANCE AND O-RING) CONFIRM THE DEVICE WAS OF THE CURRENT DESIGN. THE FOAM WAS ORIENTED CORRECTLY WITHIN THE HANDLE (SLITS POINTING DOWN TOWARDS THE RED ACTIVATION KNOB). WHEN TESTED WITH A NEW CO2 CARTRIDGE AND ACTIVATION KNOB, THE DEVICE SPRAYED AS INTENDED. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. 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 LABORATORY EVALUATION OF THE RETURNED DEVICE COULD NOT CONFIRM THE REPORT BECAUSE THE DEVICE SPRAYED AS INTENDED WHEN TESTED WITH A NEW CO2 CARTRIDGE AND ACTIVATION KNOB. THE ROOT CAUSE FOR THE REPORT OF UNABLE TO SPRAY IS UNKNOWN. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. CATHETER OCCLUSION CAN BE A CAUSE OF THIS DEVICE NOT BEING ABLE TO SPRAY POWDER. HOWEVER, WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE NO CATHETERS WERE RETURNED FOR EVALUATION. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. THE USER INDICATED THAT THEY DID NOT OCCLUDE THE RED CATHETER HUB DURING CATHETER ADVANCEMENT. THE IFU STATES: "TO LIMIT FLUID FROM ENTERING THE WORKING CHANNEL OF THE CATHETER, TEMPORARILY OCCLUDE THE PROXIMAL END OF THE CATHETER BY PLACING A THUMB OVER THE RED CATHETER HUB, WHILE ADVANCING THE CATHETER DOWN THE ACCESSORY CHANNEL." A CORRECTIVE ACTION (CAPA) WAS INITIATED TO FURTHER INVESTIGATE DEVICE FAILURE DUE TO BEING UNABLE TO SPRAY POWDER. 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. ADDITIONAL COMMENTS REGARDING THIS REPORT: THE INFORMATION PROVIDED BY THE USER INDICATES THAT THE USER DID NOT OCCLUDE THE PROXIMAL END OF THE CATHETER DURING ADVANCEMENT. 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 ESOPHAGOGASTRODUODENOSCOPY (OGDS) PROCEDURE IN THE ANTRUM OF THE STOMACH, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE HEMOSPRAY DID NOT REACT [SPRAY] DURING DEPLOYMENT. THEY IMMEDIATELY CHANGE TO ANOTHER SET OF HEMOSPRAY. 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
    1619622 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC G24663 W4575319 00827002246638

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female ENDOSCOPE OLYMPUS GIF-HQ190.