BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 11543264 · Received March 22, 2021

    Report

    Report Number
    1037905-2021-00120
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    February 21, 2021
    Report Date
    April 28, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE. PRODUCT CODE: QAU. INFORMATION REGARDING THE INITIAL REPORTER SECTION: OCCUPATION- UNKNOWN. INFORMATION REGARDING 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 (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 HAD NUMEROUS SMALL KINKS AND CONTAINED POWDER. WHEN TESTED AS RETURNED, THE DEVICE DID NOT SPRAY. THE DEVICE DID NOT DISCHARGE WHEN DEACTIVATED AND THE CO2 CARTRIDGE 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) CONFIRM THE DEVICE WAS OF THE CURRENT DESIGN. WHEN RETESTED WITH A NEW CO2 CARTRIDGE, THE DEVICE DID NOT SPRAY. THE DEVICE WAS DISASSEMBLED AND THE TUBES WERE DISCONNECTED FOR REMOVAL OF ANY POWDER. LOOSE POWDER WAS PRESENT IN THE FRONT TUBE OF THE DEVICE BETWEEN THE NOZZLE AND POWDER CHAMBER, HOWEVER THE BACK TUBE BETWEEN THE POWDER CHAMBER AND REGULATOR DID NOT CONTAIN POWDER. THE POWDER CHAMBER WAS DISASSEMBLED AND NO CLUMPS OF POWDER WERE FOUND INSIDE THE CENTER POWDER CANNULA. THE SMALLER POWDER CHAMBER CANNULA CONNECTING TO THE DIFFUSER PLACE WAS OCCLUDED WITH A LARGE AMOUNT OF POWDER. A VISUAL INSPECTION OF 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 RETURNED WITH THE DEVICE 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. NO HARD CLUMPS OF COAGULATED POWDER WERE OBSERVED INSIDE THE DEVICE, HOWEVER THE POWDER CHAMBER CANNULA LEADING FROM THE LOW PRESSURE VALVE TO THE DIFFUSER PLATE INSIDE THE POWDER CHAMBER WAS OCCLUDED WITH LOOSE POWDER. THIS IS INDICATIVE OF BACK FLOW WHICH COULD HAVE OCCURRED IF SOMETHING BLOCKED THE FLOW OF THE POWDER FURTHER ALONG THE DEVICE, SUCH AS IN THE CATHETER. 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. 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 NUMBER RETURNED WITH THE DEVICE 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.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE. PRODUCT CODE: QAU. INFORMATION REGARDING THE INITIAL REPORTER SECTION: OCCUPATION- UNKNOWN. INFORMATION REGARDING PMA/510(K): 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 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. 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 · 1

    DURING AN ENDOSCOPIC HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE PHYSICIAN TRIED TO ACTIVATE THE DEVICE, BUT THE TRIGGER BUTTON DID NOT WORK. 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
    445087 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY W4346907

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR ENDOSCOPE, UNKNOWN MAKE OR MODEL