BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 12377081 · Received August 27, 2021

    Report

    Report Number
    1037905-2021-00442
    Event Type
    Malfunction
    Date Received
    August 27, 2021
    Report Date
    November 10, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED: SECTION D: COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE, PRODUCT CODE: QAU. SECTION E. INITIAL REPORTER; OCCUPATION: NON-HEALTHCARE PROFESSIONAL. SECTION G: 510K: K200972. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A BIO BAG. INCLUDED WAS A TRAY LID FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. 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 "OFF" POSITION. THE RED ACTIVATION KNOB WAS ENGAGED IN THE HANDLE INDICATING ACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. POWDER WAS VISIBLE IN THE NOZZLE OF THE DEVICE. THE DEVICE WAS TESTED AS RETURNED AND DID NOT SPRAY AS INTENDED. UPON DEACTIVATION, THE CO2 CARTRIDGE DISCHARGED AND 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. WHEN TESTED WITH A NEW CO2 CARTRIDGE, THE DEVICE DID NOT SPRAY. THE DEVICE WAS DISASSEMBLED AND THE TUBES WERE DISCONNECTED FOR REMOVAL OF ANY POWDER. WHEN DISASSEMBLED, THE LOW PRESSURE VALVE SPRANG APART, LIKELY DUE TO BACK PRESSURE WHICH IS INDICATIVE OF AN INTERNAL CLOG. HARD, DARKENED CLUMPS OF POWDER WERE PRESENT IN THE FRONT TUBE CONNECTING THE ON/OFF VALVE TO THE POWDER CHAMBER AS WELL AS IN THE NOZZLE. LOOSE POWDER WAS PRESENT IN THE BACK TUBE CONNECTING THE POWDER CHAMBER TO THE LOW PRESSURE VALVE AND THE POWDER CHAMBER CENTER CANNULA. A VISUAL INSPECTION 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. CATHETER OCCLUSION CAN BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE. TO ASSIST THE USER, THE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, "NOTE: DO NOT TEST DEVICE PRIOR TO INSERTION INTO ENDOSCOPE ACCESSORY CHANNEL AS THIS MAY INCREASE RISK OF CATHETER OCCLUSION." THE IFU ALSO STATES, "PRECAUTION: TO AVOID CATHETER OCCLUSION, DO NOT PLACE CATHETER DIRECTLY IN CONTACT WITH BLOOD AND/OR MUCOSA, INCLUDING ANY POOLED BLOOD AND DO NOT ASPIRATE BLOOD WHILE CATHETER IS IN ACCESSORY CHANNEL. NOTE: IF CATHETER BECOMES OCCLUDED, TURN RED VALVE TO CLOSED POSITION, REMOVE CATHETER FROM ENDOSCOPE AND REPLACE WITH EXTRA CATHETER PROVIDED IN PACKAGE.". 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.

    Additional Manufacturer Narrative · 0

    CONTINUED: SECTION D: COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL. USE PRODUCT CODE: QAU. SECTION E. INITIAL REPORTER; OCCUPATION: NON-HEALTHCARE PROFESSIONAL . 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 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 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 · 0

    DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED "THE [THERE] WAS NO SPRAY COMING OUT, IT WOULD NOT DEPLOY ANY POWDER." A SECOND-NEW HEMOSPRAY WAS OPENED AND USED TO COMPLETE THE INTENDED PROCEDURE. 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.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE. PRODUCT CODE: QAU. INITIAL REPORTER; OCCUPATION: NON-HEALTHCARE PROFESSIONAL. 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. 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. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. 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 AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED "THE [THERE] WAS NO SPRAY COMING OUT, IT WOULD NOT DEPLOY ANY POWDER. A SECOND-NEW HEMOSPRAY WAS OPENED AND USED TO COMPLETE THE INTENDED 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
    1278150 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY W4423934

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ENDOSCOPE-UNKNOWN MAKE OR MODEL