BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 8190914 · Received December 21, 2018

    Report

    Report Number
    1037905-2018-00598
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    November 22, 2018
    Report Date
    November 26, 2018
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    UDI-DI
    00827002213463
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE; COMMON DEVICE NAME: NOT AVAILABLE; REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. 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 DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN THE "OFF" POSITION WITH THE RED ACTIVATION KNOB ENGAGED IN THE HANDLE FOR ACTIVATION OF THE CARBON DIOXIDE CARTRIDGE. THE POWDER CHAMBER APPEARED TO BE RATHER FULL. WHEN TESTED AS RETURNED, THE DEVICE DID NOT SPRAY. THE RED ACTIVATION HANDLE WAS REMOVED, NO CARBON DIOXIDE HAD REMAINED IN THE CARTRIDGE. THE CARBON DIOXIDE CARTRIDGE WAS PUNCTURED APPROPRIATELY. THE LANCE POSITION WAS MEASURED USING A TOOL AND FOUND TO BE POSITIONED CORRECTLY. A VISUAL EXAMINATION OF THE LANCE INSIDE THE HANDLE INDICATES IT IS BEVELED. THE O-RING AND LANCE APPEAR TO BE POSITIONED CORRECTLY INSIDE THE REGULATOR. WHEN RETESTED WITH A NEW CARBON DIOXIDE CARTRIDGE, A PUFF OF POWDER WAS EXPELLED WHEN THE SWITCHED WAS TOGGLED TO THE "ON" POSITION. THE DEVICE THEN SPRAYED POWDER AS INTENDED. 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: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. FURTHERMORE, WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE CATHETERS WERE NOT RETURNED FOR EVALUATION. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. THE INSTRUCTIONS FOR USE STATES: "IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITIONS, DO NOT USE." THE REPORT INDICATES, "IT WAS NOT POSSIBLE TO SPRAY ALSO BEFORE THE DEVICE HAS BEEN PLACED IN THE ENDOSCOPE." THE EVALUATION AND REPORT INDICATE THE DEVICE WAS USED. THE REPORT SUGGESTS THE USER TESTED THE DEVICE PRIOR TO INSERTING THE CATHETER INTO THE ENDOSCOPE, DETERMINED THE DEVICE DID NOT SPRAY OUTSIDE OF THE ENDOSCOPE, AND THEN ATTEMPTED TO USE THE NONFUNCTIONING DEVICE IN THE ENDOSCOPE. 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 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

    DURING A HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE CARTRIDGE COULD NOT BE ACTIVATED CORRECTLY. THEY ACTIVATED THE CARBON DIOXIDE CARTRIDGE BUT COULD NOT SPRAY [POWDER]. PER THE COOK SALES REPRESENTATIVE, "I SUSPECT THAT THE CARBON DIOXIDE CARTRIDGE HAS NOT OPENED [BEEN PUNCTURED]. IT WAS NOT POSSIBLE TO SPRAY, ALSO BEFORE THE DEVICE HAS BEEN PLACED IN THE ENDOSCOPE [DEVICE ALSO DID NOT SPRAY PRIOR TO USE]." 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
    1031759 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY W4017240 00827002213463

    Patients

    Seq Age Sex Outcome Treatment
    1