BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 14980854 · Received July 11, 2022

    Report

    Report Number
    1037905-2022-00374
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Date of Event
    June 14, 2022
    Report Date
    August 12, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    UDI-DI
    00827002246638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE SECTION. COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE PROCODE: QAU. 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. 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

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE SECTION. COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE PROCODE: QAU INFORMATION REGARDING ALL MANUFACTURERS SECTION: PMA/510(K): K200972. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN 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 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. THE DEVICE WAS TESTED AS RETURNED AND DID NOT SPRAY AS INTENDED. THE CO2 CARTRIDGE DID NOT DISCHARGE UPON DEACTIVATION 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 AS INTENDED. THE DEVICE WAS DISASSEMBLED AND THE TUBES WERE DISCONNECTED FOR REMOVAL OF ANY POWDER. LOOSE POWDER WAS PRESENT IN THE FRONT TUBE CONNECTING THE ON/OFF VALVE TO THE POWDER CHAMBER AND BACK TUBE CONNECTING THE POWDER CHAMBER TO THE LOW PRESSURE VALVE. A VISUAL INSPECTION OF THE POWDER CHAMBER CENTER CANNULA AND HOLE IN THE BOTTOM OF THE POWDER CHAMBER SHOWED IT TO BE CLEAR. THE LOW PRESSURE VALVE WAS DISASSEMBLED AND EVALUATED. ALL THE INTERNAL COMPONENTS WERE INTACT. HOWEVER, POWDER WAS OBSERVED 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 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.

    Description of Event or Problem · 0

    DURING A HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE GAS DID NOT COME OUT; IT SEEMED LIKE THERE WAS NO GAS [UNABLE TO SPRAY]. 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
    2397229 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU WILSON-COOK MEDICAL INC W4559698 00827002246638

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OLYMPUS GASTROSCOPE, UNKNOWN MODEL