BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 10771574 · Received November 2, 2020

    Report

    Report Number
    1037905-2020-00464
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    September 22, 2020
    Report Date
    December 10, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    UDI-DI
    00827002565722
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE SECTION COMMON DEVICE NAME: NOT AVAILABLE REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE PRODUCT CODE: QAU INFORMATION REGARDING ALL MANUFACTURERS SECTION 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. POWDER WAS NOTED ON THE INSIDE OF THE NOZZLE OF THE DEVICE. WHEN TESTED AS RETURNED, THE DEVICE DID NOT SPRAY. 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 INITIALLY DID NOT SPRAY, THEN LET OUT A BURST OF POWDER AND SPRAYED CONSTANTLY WITHOUT PRESSING THE ACTIVATION BUTTON. THE CATHETER WAS ATTACHED TO THE DEVICE FOR TESTING AND SHOWN TO BE CLEAR AS THE DEVICE CONTINUED TO SPRAY CONSTANTLY. THE DEVICE WAS DISASSEMBLED AND POWDER WAS SEEN IN THE TUBES CONNECTING THE POWDER CHAMBER, ON/OFF VALVE, AND LOW PRESSURE VALVE. THE TUBES WERE DISCONNECTED FOR REMOVAL OF THE POWDER AND NO CLUMPS WERE OBSERVED. A VISUAL INSPECTION OF HOLE IN THE BOTTOM OF THE POWDER CHAMBER SHOWED IT TO BE CLEAR. THE LOW PRESSURE VALVE WAS DISSEMBLED AND EVALUATED. ALL THE INTERNAL COMPONENTS WERE INTACT. HOWEVER, POWDER WAS OBSERVED ALONG THE INSIDE WALL OF THE VALVE, AROUND THE BASE OF THE ACTIVATION BUTTON, AND AROUND THE O-RINGS INSIDE THE VALVE. 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: POWDER WAS OBSERVED AROUND THE COMPONENTS AND O-RINGS INSIDE THE LOW PRESSURE VALVE. IT IS UNKNOWN HOW THE POWDER ENTERED THE VALVE. IT IS POSSIBLE THAT PRESSURE BACK FLOW OCCURRED DUE TO POWDER CLOGGING THE DEVICE AND/OR CATHETERS OR DUE TO THE CARBON DIOXIDE CARTRIDGE EMPTYING COMPLETELY, WHICH CAN SEND POWDER BACK INTO THE LOW PRESSURE VALVE AND CAUSE THE OBSERVATIONS FOUND DURING THE EVALUATION. 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 THE ONLY ONE CATHETER WAS 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.

    Description of Event or Problem · 0

    DURING A HEMOSTASIS PROCEDURE, THE PHYSICIAN SELECTED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE PHYSICIAN RELEASED THE DUST [POWDER] AND IT DID NOT COME OUT. THE TREATMENT WAS NOT PERFORMED. SCLEROTHERAPY WITH INJECTOR AND SCLEROSING DRUG WAS PERFORMED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED SCLEROTHERAPY WITH INJECTOR AND SCLEROSING DRUG 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: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. PRODUCT CODE: QAU. INFORMATION REGARDING THE INITIAL REPORTER SECTION OCCUPATION: UNKNOWN. INFORMATION REGARDING ALL MANUFACTURERS SECTION 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. 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 WAS 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 A HEMOSTASIS PROCEDURE, THE PHYSICIAN SELECTED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE PHYSICIAN RELEASED THE DUST [POWDER] AND IT DID NOT COME OUT. THE TREATMENT WAS NOT PERFORMED. SCLEROTHERAPY WITH INJECTOR AND SCLEROSING DRUG WAS PERFORMED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED SCLEROTHERAPY WITH INJECTOR AND SCLEROSING DRUG 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
    1233558 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY G56572 W4157000 00827002565722

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention PENTAX ENDOSCOPE, UNKNOWN MODEL| PENTAX ENDOSCOPE, UNKNOWN MODEL