BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 10855775 · Received November 17, 2020

    Report

    Report Number
    1037905-2020-00487
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    October 24, 2020
    Report Date
    November 17, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    UDI-DI
    00827002246638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE SECTION: COMMON DEVICE NAME: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE PRODUCT CODE: QAU. PMA/510(K) # K200972. INITIAL REPORTER OCCUPATION: UNKNOWN. 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. WHILE THE CO2 CARTRIDGE AND POWDER CHAMBER ARE DESIGNED TO EMPTY AT APPROXIMATELY THE SAME TIME, THE RATIO OF CO2 TO POWDER USED CAN VARY DEPENDING ON USE OF THE DEVICE. HOLDING THE ACTIVATION BUTTON DOWN FOR AN EXTENDED PERIOD OF TIME CAN CAUSE THE RATIO TO CHANGE SUCH THAT THE CO2 CARTRIDGE EMPTIES PRIOR TO THE POWDER CHAMBER EMPTYING. THIS MAY HAVE CONTRIBUTED TO THE REPORTED OBSERVATION. 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 AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT TO TREAT AN UPPER GASTROINTESTINAL BLEEDING. THE NURSE SET UP THE DEVICE AND DEPRESSED THE RED TRIGGER APPLYING HEMOSPRAY AS PER SURGEON'S REQUEST WITH NO PROBLEM. AFTER USING AROUND A THIRD OF THE POWDER, THE SURGEON REQUESTED ONE FINAL BURST OF SPRAY, BUT THE POWDER WOULD NOT DEPLOY. THEY CHECKED THE CATHETER WITH NO SIGN OF EMBOLIZATION AND EVEN TRIED THE SECOND CATHETER WITH NO SUCCESS. WHEN THEY ROTATED THE RED KNOB COUNTERCLOCKWISE TO CHECK FOR SIGN OF DEPRESSURE FROM THE CO2 CARTRIDGE, THERE WERE NO SIGN OF DEPRESSURIZATION CONFIRMING THAT THERE WAS NOT ENOUGH CO2 GAS IN THE CARTRIDGE TO KEEP USING THIS HEMOSPRAY. DESPITE THE FACT THAT IT STILL HAD AROUND TWO THIRD OF THE POWDER LEFT IN THE GUN. UNFORTUNATELY, THE HEMOSPRAY WAS DISPOSED THEREFORE CANNOT BE RETURNED FOR EVALUATION. OTHER THAN THE DEPLOYED POWDER, 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
    1322827 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY W4351539 00827002246638

    Patients

    Seq Age Sex Outcome Treatment
    1