BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 13759789 · Received March 14, 2022

    Report

    Report Number
    1037905-2022-00110
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    February 11, 2022
    Report Date
    April 28, 2022
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    UDI-DI
    00827002213463
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE. PRODUCT CODE: QAU. 510K: K200972. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    CONTINUED: SECTION D: COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE PRODUCT CODE: QAU. SECTION G: 510K: K200972. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    CONTINUED: SECTION D: COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE PRODUCT CODE: QAU. SECTION G: 510K: K200972. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM 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 EXTERIOR OF THE DEVICE PRESENTED WITH POWDER ON IT. THE DEVICE WAS TESTED AS RETURNED AND DID NOT SPRAY AS INTENDED. THE CO2 CARTRIDGE DID NOT DISCHARGE 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. 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: OUR EVALUATION OF THE RETURNED DEVICE COULD NOT CONFIRM THE OCCURRENCE BECAUSE THE DEVICE SPRAYED AS INTENDED. HOWEVER THE REPORT INDICATES THAT "THE GAS WENT OUT DURING INITIATING". THEREFORE THE MOST LIKELY CAUSE OF THIS OCCURRENCE IS THAT THE ACTIVATION KNOB WAS NOT FULLY ENGAGED AT THE TIME THE CO2 CARTRIDGE WAS PUNCTURED, CAUSING THE CO2 TO ESCAPE OUT OF THE DEVICE. THE COMPLAINT IS CONSIDERED CONFIRMED BASED ON THE REPORT. WHEN ACTIVATED, THE DEVICE CAN SOMETIMES HISS OR RELEASE A SMALL AMOUNT OF CO2 AS THE USER TWISTS TOWARD THE ACTIVATION POSITION. THIS SOUND IS NOT INDICATIVE OF DEVICE FAILURE OR ISSUE, RATHER IT IS THE SOUND OF CO2 EXITING THE INNER CHAMBER OF THE DEVICE AND INDICATES THE CHAMBER IS NOT SEALED AND THE ACTIVATION KNOB IS NOT IN THE ACTIVATION POSITION. THE IFU INSTRUCTS THE USER, "ACTIVATE CO2 CARTRIDGE BY TURNING RED ACTIVATION KNOB UNTIL IT STOPS.". 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 AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE GAS "WENT OUT" DURING INITIATING [ACTIVATION] & "HANDLE WENT WARM." 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
    1353526 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY W4349189 00827002213463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ENDOSCOPE-UNKNOWN MAKE OR MODEL