BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 8729144 · Received June 24, 2019

    Report

    Report Number
    1037905-2019-00348
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Report Date
    May 30, 2019
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    MGB
    UDI-DI
    00827002246638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    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: 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.

    Description of Event or Problem · 0

    DURING A HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. DURING PREPARATION, THE NURSE STATED THAT THEY PREPARED THE DEVICE AND HANDED THE HANDLE TO THE PHYSICIAN. WHEN IT WAS HANDED BACK TO THE NURSE, THE HANDLE WAS COLD. ONCE THE DEVICE WAS DOWN THE ENDOSCOPE, THEY ATTEMPTED TO SPRAY THE DEVICE AND NO POWDER COULD BE SPRAYED. 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.

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE: COMMON DEVICE NAME: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE. PMA/510K: DEN170015. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT WITH PRODUCT EVALUATION INFORMATION.

    Description of Event or Problem · 1

    DURING A HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. DURING PREPARATION, THE NURSE STATED THAT THEY PREPARED THE DEVICE AND HANDED THE HANDLE TO THE PHYSICIAN. WHEN IT WAS HANDED BACK TO THE NURSE, THE HANDLE WAS COLD. ONCE THE DEVICE WAS DOWN THE ENDOSCOPE, THEY ATTEMPTED TO SPRAY THE DEVICE AND NO POWDER COULD BE SPRAYED. 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
    523108 HEMOSPRAY ENDOSCOPIC HEMOSTAT MGB COOK ENDOSCOPY W4193355 00827002246638

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GASTROSCOPE - UNKNOWN MODEL