BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 12091730 · Received June 30, 2021

    Report

    Report Number
    1037905-2021-00289
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 9, 2021
    Report Date
    July 19, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    UDI-DI
    00827002565722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE SECTION COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE PRODUCT CODE: QAU INFORMATION REGARDING PMA/510(K): K200972. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A OPEN TRAY 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 INCLUDED IN THE RETURN. 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. ONE OF THE RETURNED CATHETERS (CATHETER #1) PRESENTED WITH BROWN/RED COLORED POWDER IN THE TUBING AND DISCOLORATION AT THE TIP. THE OTHER CATHETER (CATHETER #2) DID NOT PRESENT WITH ANY VISIBLE KINKS OR POWDER INSIDE THE TUBING. THE RETURNED DEVICE PRESENTED WITH BLOOD ON THE EXTERIOR. WHEN TESTED AS RETURNED THE DEVICE SPRAYED AS INTENDED. CATHETER #1 WAS ATTACHED AND DID NOT SPRAY. CATHETER #2 WAS ATTACHED AND 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. WHEN TESTED WITH A NEW CO2 CARTRIDGE AND ACTIVATION KNOB, THE DEVICE SPRAYED AS INTENDED. THE RETURNED CATHETERS WAS ATTACHED FOR TESTING. CATHETER #1 DID NOT SPRAY AS INTENDED WHEN TESTED. CATHETER #2 SPRAYED AS INTENDED WHEN TESTED. 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 IS A CLOGGED CATHETER. CATHETER #1 IS CLOGGED WITH DISCOLORED HEMOSPRAY POWDER. HOWEVER, THE DEVICE FUNCTIONED AS INTENDED WITHOUT THE USE OF CATHETERS AS WELL AS WITH CATHETER #2. THE LIKELY CAUSE OF THE CLOGGED CATHETER IS RELATED TO BLOOD OR OTHER FLUID FROM THE SURROUNDING AREA CLOGGING THE DEVICE DUE TO USE ERROR. THIS IS INDICATED BY CATHETER #1 BEING UNABLE TO SPRAY AS WELL AS THE FLUID AND DISCOLORED POWDER THAT EXITED CATHETER #2. TO ASSIST THE USER, THE INSTRUCTIONS FOR USE (IFU) STATE THE FOLLOWING, "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 COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED THAT THE CATHETER CAME INTO CONTACT WITH BLOOD, A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Additional Manufacturer Narrative · 1

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE: COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE. PRODUCT CODE: QAU. INFORMATION REGARDING PMA/510(K): K200972. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE SENT FOLLOWING COMPLETION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE DEVICE DIDN'T WORK. THEY WENT DOWN THE SCOPE AND TRIED TO ACTIVATE THE CARBON DIOXIDE (CO2) AND THE CO2 DIDN'T WORK. THE USER TROUBLESHOT UNSUCCESSFULLY. THE USER TOOK THE DEVICE OUT OF THE SCOPE AND USED ANOTHER HEMOSPRAY TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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
    994167 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY G56572 W4416606 00827002565722

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE, UNKNOWN MODEL.