BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 8282779 · Received January 28, 2019

    Report

    Report Number
    1037905-2019-00032
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Report Date
    January 3, 2019
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    UDI-DI
    00827002210493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION REGARDING SECTION D2- SUSPECT MEDICAL DEVICE COMMON DEVICE NAME: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. INFORMATION REGARDING SECTION G5 DEN170015. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. HOWEVER, ALL THE COMPONENTS WERE NOT INCLUDED IN THE RETURN (NO RETURNED CATHETERS) THEREFORE, A COMPLETE EVALUATION WAS NOT POSSIBLE. THE RED ACTIVATION KNOB WAS ENGAGED AND THE ¿ON/OFF¿ SWITCH WAS ON. WHEN TESTED AS RETURNED, THE DEVICE LET OUT A VERY SMALL PUFF OF POWDER BUT NO SPRAY. WHEN THE RED ACTIVATION HANDLE WAS REMOVED, A LOT OF CARBON DIOXIDE REMAINED IN THE CARTRIDGE. THE CARBON DIOXIDE WAS PUNCTURED CORRECTLY. AFTER A VISUAL INSPECTION, HARDENED POWDER WAS FOUND IN THE DISTAL OPENING OF THE DEVICE. THE LANCE POSITION WAS MEASURED USING A TOOL AND FOUND TO BE POSITIONED CORRECTLY. A VISUAL EXAMINATION OF THE O-RING SHOWED THAT IT WAS NOT SITTING FLUSH ON TOP OF THE LANCE. THE O-RING WAS REMOVED AND THE LANCE, SPRING AND BALL INSIDE THE REGULATOR FELL OUT. THE INSPECTION OF THE CARBON DIOXIDE CARTRIDGE AND REGULATOR (LANCE AND O-RING) CONFIRM THE DEVICE IS OF THE POST-CAPA DESIGN. THE DEVICE WAS DISASSEMBLED AND THE TUBES WERE DISCONNECTED FOR REMOVAL OF THE POWDER. CLUMPS OF DARKENED POWDER WERE FOUND IN THE TUBE BETWEEN THE ON/OFF SWITCH AND LOW-PRESSURE VALVE. THE CLUMPS APPEAR RED IN NATURAL LIGHT. A VERY SMALL AMOUNT OF POWDER WAS OBSERVED IN THE TUBE BETWEEN THE POWDER CHAMBER AND LOW-PRESSURE VALVE. POWDER INSIDE THE TUBE LEADING FROM THE POWDER CHAMBER TO THE SMALL GRAY LOW-PRESSURE VALVE CAN OCCUR IF THERE IS A BACK FLOW OF PRESSURE. BACK FLOW CAN OCCUR FROM AN INTERNAL OR CLOGGED CATHETER, OR IF THE CARBON DIOXIDE CARTRIDGE RUNS OUT OF GAS. THE LOW-PRESSURE VALVE WAS DISASSEMBLED AND A SMALL AMOUNT OF POWDER WAS FOUND INSIDE. A VISUAL OF THE HOLE IN THE BOTTOM OF THE POWDER CHAMBER SHOWED IT TO BE CLEAR. THERE IS CLUMPED POWDER ADHERING TO THE INNER WALL OF THE LARGE CANNULA THAT GOES INTO THE POWDER CHAMBER. REPORT INDICATES THE DEVICE WAS PRIOR TO USE, BUT THE RED CLUMPS OF POWDER IN THE DEVICE SUGGEST THE DEVICE WAS USED, INDICATING CONTACT WITH BLOOD. 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. ALTHOUGH THE LANCE POSITION WAS SLIGHTLY DISPLACED, IT WAS NOT THE ROOT CAUSE OF THE DEVICE BEING UNABLE TO SPRAY POWDER. 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 CATHETERS WERE NOT RETURNED FOR EVALUATION. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. CATHETER OCCLUSION CAN BE A CAUSE OF THIS DEVICE NOT BEING ABLE TO SPRAY POWDER. CATHETER OCCLUSION CAN BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE. TO ASSIST THE USER, THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "NOTE: DO NOT TEST DEVICE PRIOR TO INSERTION INTO ENDOSCOPE ACCESSORY CHANNEL AS THIS MAY INCREASE RISK OF CATHETER OCCLUSION... 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 RECORDS CONFIRMED THAT THE POSSIBLE LOT NUMBERS 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

    THE FOLLOWING WAS REPORTED TO THE FDA ON 28-JAN-2019: "IN PREPARATION FOR A HEMOSTASIS PROCEDURE, THE PHYSICIAN SELECTED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE UNIT WAS ACTIVATED (PRESSURIZED), BUT WOULD NOT DEPLOY POWDER. A SECOND UNIT WAS USED TO COMPLETE THE CASE. PRESSURIZING THE HEMOSPRAY, A PREPARATION STEP, MEANS THIS PRODUCT (CATHETER) NEVER WAS ADVANCED INTO THE ENDOSCOPE OR ANYWHERE NEW THE PATIENT [SIC]." THE DEVICE MALFUNCTION WAS REPORTED TO BE PRIOR TO USE, BUT DURING THE DEVICE EVALUATION, RED POWDER WAS FOUND ON THE DEVICE INDICATING BLOOD CONTACT. THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT. BECAUSE THE COMPLAINANT STATED THAT THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT, WE CAN CONCLUDE THAT THIS INFORMATION DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE: COMMON DEVICE NAME: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. INFORMATION REGARDING SECTION PMA: DEN170015. 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.

    Description of Event or Problem · 1

    IN PREPARATION FOR A HEMOSTASIS PROCEDURE, THE PHYSICIAN SELECTED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE UNIT WAS ACTIVATED (PRESSURIZED), BUT WOULD NOT DEPLOY POWDER. A SECOND UNIT WAS USED TO COMPLETE THE CASE. PRESSURIZING THE HEMOSPRAY, A PREPARATION STEP, MEANS THIS PRODUCT (CATHETER) NEVER WAS ADVANCED INTO THE ENDOSCOPE OR ANYWHERE NEW THE PATIENT [SIC]. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73348 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY G21049 W4118900 00827002210493

    Patients

    Seq Age Sex Outcome Treatment
    1