BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 10650743 · Received October 8, 2020

    Report

    Report Number
    1037905-2020-00430
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Date of Event
    September 11, 2020
    Report Date
    October 8, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    UDI-DI
    00827002565722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE SECTION. COMMON DEVICE NAME: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. PRODUCT CODE: QAU. INFORMATION REGARDING THE INITIAL REPORTER SECTION. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. INFORMATION REGARDING ALL MANUFACTURERS SECTION. PMA/510(K) #: K200972. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT. ALL COMPONENTS WERE NOT INCLUDED IN THE RETURN (ONLY ONE CATHETER WAS 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. THE RETURNED CATHETER WAS KINKED. WHEN TESTED AS RETURNED, THE DEVICE SPRAYED AS INTENDED. THE CO2 CARTRIDGE DISCHARGED WHEN DEACTIVATED AND WAS FULLY PUNCTURED. THE LANCE POSITION WAS MEASURED AND FOUND TO BE POSITIONED CORRECTLY. 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) CONFIRMS THE DEVICE WAS OF THE CURRENT DESIGN. WHEN TESTED WITH A NEW CO2 CARTRIDGE AND ACTIVATION KNOB, THE DEVICE SPRAYED AS INTENDED. THE CATHETER WAS ATTACHED AND 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 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. HOWEVER, WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE ONLY ONE CATHETER WAS RETURNED FOR EVALUATION. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. A CORRECTIVE ACTION HAS BEEN INITIATED CONCERNING DEVICE FAILURE DUE TO BEING UNABLE TO SPRAY POWDER. 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 WAS 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 · 1

    DURING A HEMOSTASIS PROCEDURE, THE PHYSICIAN SELECTED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE CARBON DIOXIDE (CO2) UNKNOWINGLY MALFUNCTIONED. THE PHYSICIAN USED ANOTHER OF THE SAME PRODUCT TO COMPLETE THE PROCEDURE. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118224 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY G56572 W4366711 00827002565722

    Patients

    Seq Age Sex Outcome Treatment
    1