BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 10969068 · Received December 8, 2020

    Report

    Report Number
    1037905-2020-00537
    Event Type
    Injury
    Date Received
    December 8, 2020
    Date of Event
    November 16, 2020
    Report Date
    April 7, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    UDI-DI
    00827002210493
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 0

    DURING A COLONOSCOPY, THE PHYSICIAN AND NURSE USED HEMOSPRAY ENDOSCOPIC HEMOSTAT FOR A POST-POLYPECTOMY BLEED. THE NURSE REPORTED AN ISSUE WITH ONE THE HEMOSPRAY UNITS WHICH OCCURRED ON MONDAY (B)(6) 2020. THE NURSE SET THE HEMOSPRAY UP AND IT WOULD NOT SPRAY. IT MADE A VERY SOFT NOISE AND THE NURSE COULD SEE THE POWDER IN THE CANISTER MOVE A LITTLE BIT, BUT IT WOULD NOT SPRAY WITH ANY FORCE TO TRAVEL DOWN THE CHANNEL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE AFFECTED AREA WAS ULTIMATELY INJECTED WITH EPINEPHRINE/SALINE AND A CLIP WAS APPLIED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    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. 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. POWDER WAS VISIBLE INSIDE THE NOZZLE OF THE DEVICE. WHEN TESTED AS RETURNED, THE DEVICE DID NOT SPRAY. THE CO2 CARTRIDGE DISCHARGED UPON DEACTIVATION OF THE DEVICE AND THE CO2 CARTRIDGE WAS FULLY PUNCTURED. AT THIS POINT IN THE EVALUATION, THE COMPONENTS OF THE REGULATOR POPPED OUT OF PLACE. THE LANCE, SPRING, BALL, AND TWO O-RINGS WERE ALL ACCOUNTED FOR. THE LANCE APPEARED TO BE CORRECTLY BEVELED. THE INSPECTION OF THE CO2 CARTRIDGE, LANCE, AND BLACK O-RING CONFIRMS THE DEVICE WAS OF THE CURRENT DESIGN. FOR FURTHER EVALUATION, THE DEVICE WAS DISASSEMBLED AND THE TUBES WERE DISCONNECTED FOR REMOVAL OF THE POWDER. HARD CLUMPS OF POWDER WERE OBSERVED IN THE NOZZLE. THE TUBE BETWEEN THE POWDER CHAMBER AND ON/OFF VALVE, THE BACK TUBE BETWEEN THE POWDER CHAMBER AND REGULATOR, AND THE POWDER CHAMBER CANNULA CONTAINED LOOSE POWDER. A VISUAL OF THE HOLE IN THE BOTTOM OF THE POWDER CHAMBER SHOWED IT TO BE CLEAR. 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 REPORT OF UNABLE TO SPRAY WAS AN INTERNAL CLOG WITHIN THE DEVICE. THE CAUSE OF THE INTERNAL CLOG 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 INTERNALLY CLOGGING AND 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. 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: 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 COLONOSCOPY, THE PHYSICIAN AND NURSE USED HEMOSPRAY ENDOSCOPIC HEMOSTAT FOR A POST-POLYPECTOMY BLEED. THE NURSE REPORTED AN ISSUE WITH ONE THE HEMOSPRAY UNITS WHICH OCCURRED ON MONDAY (B)(6) 2020. THE NURSE SET THE HEMOSPRAY UP AND IT WOULD NOT SPRAY. IT MADE A VERY SOFT NOISE AND THE NURSE COULD SEE THE POWDER IN THE CANISTER MOVE A LITTLE BIT, BUT IT WOULD NOT SPRAY WITH ANY FORCE TO TRAVEL DOWN THE CHANNEL. 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 THAT WAS REPORTED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE AFFECTED AREA WAS ULTIMATELY INJECTED WITH EPINEPHRINE/SALINE AND A CLIP WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428991 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY G21049 W4376255 00827002210493

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE, UNKNOWN MANUFACTURER OR MODEL