BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 8078400 · Received November 16, 2018

    Report

    Report Number
    1037905-2018-00531
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    October 24, 2018
    Report Date
    October 24, 2018
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    UDI-DI
    00827002246638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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. PMA/510K: DEN170015. (B)(4). INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS PERFORMED ONLY BY THE PHOTOS PROVIDED, BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. PER THE PHOTOS PROVIDED, WE CANNOT COMPLETE A FULL EVALUATION. POWDER APPEARS TO BE ON AND AROUND THE ENDOSCOPE. WITHOUT THE PRODUCT OR SUBSTANTIAL EVIDENCE TO CONTRADICT THE COMPLAINT, IT IS CONSIDERED CONFIRMED BASED SOLELY ON THE PHOTOS PROVIDED AND STATEMENTS DESCRIBING THE EVENT. 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 CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS FAILURE MODE. THE REPORT INDICATED THE POWDER TEMPORARILY ADHERED THE ENDOSCOPE TO TISSUE. OVERALL CLINICAL SUCCESS WAS ACHIEVED WITH THE USE OF THE HEMOSPRAY DEVICE. 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: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT IS INCLUDED IN THE SCOPE OF THIS CORRECTIVE ACTION. 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 HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE FOLLOWING INFORMATION WAS RECEIVED VIA THE COOK MEDICAL WEBSITE: "I AM WRITING TO ENQUIRE WHETHER YOU HAVE PREVIOUSLY ENCOUNTERED ANY PROBLEMS WITH HEMOSPRAY CAUSING THE GASTROSCOPE TO GET STUCK TO THE MUCOSA. I RECENTLY TREATED AN ULCER JUST BELOW THE GOJ [GASTRO-ESOPHAGEAL JUNCTION] THAT I COULD ONLY SEE IN THE RETROFLEXED POSITION. I APPLIED HEMOSPRAY TO THE ULCER AND TO THE SURROUNDING MUCOSA, AS THERE WAS SEVERE OESOPHAGITIS. I THEREFORE DID THIS IN THE RETROFLEXED POSITION AND THEREFORE SOME HEMOSPRAY WAS ALSO ON THE ENDOSCOPE. ON RETURNING TO A FORWARD POSITION, I WAS UNABLE TO REMOVE THE GASTROSCOPE. I WAS NOT AWARE THAT THERE WAS ADVICE ABOUT NOT APPLYING HEMOSPRAY IN THE RETROFLEXED POSITION. EVENTUALLY WE HAD TO TAKE THE PATIENT TO THEATRE [HOSPITAL OR] TO GIVE HIM GA [GENERAL ANESTHESIA] AND PROTECT HIS AIRWAY [INTUBATION]. WE THEN WASHED OFF THE HEMOSPRAY AND I WAS UNABLE TO REMOVE THE GASTROSCOPE. NO ONE THAT I HAVE SPOKEN TO HAS COME ACROSS THIS PROBLEM BEFORE. I HAVE HAD TO DATIX [INCIDENT REPORTING SOFTWARE] THE INCIDENT AND I HAVE STIPULATED THAT I WOULD CONTACT THE MANUFACTURER, AND I WOULD THEREFORE BE GRATEFUL FOR A FORMAL REPLY". THE FOLLOWING FURTHER INFORMATION WAS RECEIVED ON 02-NOV-2018: TWO (2) SENIOR COLLEAGUES WERE CALLED TO SEE IF THEY COULD REMOVE THE ENDOSCOPE, AND THEY BOTH FAILED AS WELL. AFTER THE PATIENT WAS ADMITTED TO THE THEATRE (OR), THEY WERE ABLE TO WASH THE HEMOSPRAY FROM THE ENDOSCOPE AND REMOVE IT WITHOUT INJURY THE PATIENT. THEY WERE CONCERNED ABOUT PROTECTING THE PATIENT'S AIRWAY PRIOR TO USING IRRIGATION TO WASH THE HEMOSPRAY OFF THE ENDOSCOPE. THE PATIENT'S ESOPHAGUS WAS NORMAL DIAMETER AND THE BLEED WAS CATEGORIZED AS OOZING. PER THE PHYSICIAN, THERE WAS SIGNIFICANT DISTRESS AND PAIN FROM THE ENDOSCOPE BEING STUCK. THE PHYSICIAN REPORTED NO CONCERNS ABOUT THE CONDITION OF THE ENDOSCOPE, AND THAT A WATER-BASED LUBRICATING GEL WAS USED AS PER STANDARD PROCEDURE. THE ENDOSCOPE WAS IN THE PATIENT'S BODY FOR 15 MINUTES PRIOR TO THE USE OF HEMOSPRAY. PRIOR TO THE USE OF HEMOSPRAY, 7ML ADRENALIN WAS USED TO ATTEMPT HEMOSTASIS. ONE (1) HEMOSPRAY DEVICE WAS USED, AND ONLY ABOUT TEN PERCENT OF THE POWDER WAS USED. IT WAS SPRAYED FOR FIVE (5) SECONDS. HEMOSTASIS WAS ACHIEVED. POOLED BLOOD DID NOT COME INTO CONTACT WITH THE SHAFT OF THE ENDOSCOPE, BUT THERE WAS AN OOZING BLEED ADJACENT TO THE AREA WHERE THE ENDOSCOPE BECAME STUCK. THE HEMOSPRAY WAS APPLIED WITH ENDOSCOPE IN A RETROFLEXED POSITION, SO THE SHAFT OF THE ENDOSCOPE WAS COATED IN A GREY SLOUGH-LIKE SPRAY 15 CM FROM THE DISTAL END. THE PHYSICIAN SAID NO CAST WAS FORMED, BUT THE PHOTOS PROVIDED BY THE PHYSICIAN SUGGEST THAT A CAST WAS FORMED AROUND THE GASTROSCOPE SHAFT. THIS WAS NOT STICKY AND WAS STRAIGHTFORWARD TO REMOVE [WITH IRRIGATION]. THE FIRST PHOTO DEMONSTRATES THAT THE ENDOSCOPE IS IN A RETROFLEXED POSITION AND BLEEDING IS NOTED. THE SECOND IMAGE SHOWS THAT THERE IS A GREY-WHITE MATERIAL PRESUMABLY ADHERING TO BOTH THE TISSUE AND THE ENDOSCOPE AND NO BLEEDING IS NOTED. THE THIRD IMAGE SHOWS ALSO THE GREY-WHITE MATERIAL PRESUMABLY ADHERING TO THE ENDOSCOPE AND THE TISSUE. HOWEVER, IT IS UNABLE TO BE DETERMINED BY THE PHOTOS IF THE ENDOSCOPE IS ADHERED TO THE TISSUE. OTHER THAN THE HEMOSPRAY POWDER, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT WAS ADMITTED TO THE OPERATING ROOM TO RECEIVE GENERAL ANESTHESIA AND HAVE THEIR AIRWAY PROTECTED DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY PHYSICAL HARM DUE TO THIS OCCURRENCE, BUT THERE WAS SIGNIFICANT DISTRESS AND PAIN, AND POST-EVENT PSYCHOLOGICAL TRAUMA WAS EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917378 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY W4101825 00827002246638

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention