BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 10719597 · Received October 22, 2020

    Report

    Report Number
    1037905-2020-00454
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Date of Event
    September 24, 2020
    Report Date
    October 22, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    UDI-DI
    00827002565722
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE: COMMON DEVICE NAME: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. PRODUCT CODE: QAU. INFORMATION REGARDING ALL MANUFACTURERS: PMA/510(K) #: K200972. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. ALL COMPONENTS WERE NOT 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 "ON" POSITION. THE RED ACTIVATION KNOB WAS ENGAGED IN THE HANDLE INDICATING ACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. WHEN TESTED AS RETURNED, THE DEVICE DID NOT SPRAY. THE ACTIVATION BUTTON APPEARED TO BE LOOSE AND DID NOT DEPRESS CORRECTLY WHEN PUSHED. THE DEVICE DID NOT DISCHARGE WHEN DEACTIVATED. 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) CONFIRM THE DEVICE WAS OF THE CURRENT DESIGN. WHEN RETESTED WITH A NEW CO2 CARTRIDGE, THE DEVICE DID NOT SPRAY AND HISSING FROM INSIDE THE DEVICE WAS AUDIBLE. THE DEVICE WAS DISASSEMBLED. THE LOW PRESSURE VALVE HAD SEPARATED; THE INTERNAL SPRING AND VALVE PLUG WERE LOOSE INSIDE THE HANDLE. 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 UNABLE TO SPRAY IS UNKNOWN, HOWEVER THE LOW PRESSURE VALVE LEAKING AND SEPARATING IS THE MOST LIKELY CAUSE. A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTAT DEVICES 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: 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 · 1

    DURING A HEMOSTASIS PROCEDURE, THE PHYSICIAN SELECTED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE DEVICE INITIALLY FIRED [SPRAYED] BUT WOULD NOT FIRE AGAIN. THE PHYSICIAN SWITCHED TO THE SECOND CATHETER BUT IT STILL WOULD NOT WORK. ADDITIONAL INFORMATION RECEIVED ON 29 SEPTEMBER 2020 STATED: THE PHYSICIAN ACHIEVED HEMOSTASIS WITH THE DEVICE IN QUESTION. THEY WANTED TO APPLY MORE [POWDER] BUT WERE UNABLE TO DO SO. THE NURSE DISENGAGED THE SAFETY TO OPERATE THE DEVICE BUT THEY DID NOT DISENGAGE THE ACTIVATION KNOB. THE DEVICE WAS RECEIVED 05 OCTOBER 2020. THE INITIAL DEVICE EVALUATION DISCOVERED THAT THE VALVE WAS BROKEN. OTHER THAN THE DEPLOYED POWDER, 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
    1187997 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY G56572 W4354322 00827002565722

    Patients

    Seq Age Sex Outcome Treatment
    1