BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 10684167 · Received October 15, 2020

    Report

    Report Number
    1037905-2020-00441
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Report Date
    October 15, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    UDI-DI
    00827002565722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    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. INFORMATION REGARDING ALL MANUFACTURERS SECTION PMA/510(K) #: K200972. 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. HOWEVER, THE REPORT INDICATES THAT THE CATHETERS USED WERE KINKED DURING THE PROCEDURE WHICH IS THE MOST LIKELY CAUSE FOR THIS OCCURRENCE. THE CAUSE OF THE KINKING IS UNKNOWN. THE INSTRUCTIONS FOR USE STATE, "SLOWLY ADVANCE CATHETER THROUGH ACCESSORY CHANNEL IN SHORT INCREMENTS UNTIL CATHETER TIP IS VISUALIZED ENDOSCOPICALLY." ADVANCING THE CATHETER SLOWLY IN SHORT INCREMENTS WILL AID IN PRESERVATION OF THE 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: 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 SELECTED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE DEVICE WAS ACTIVATED AND THE CATHETER WAS ADVANCED DOWN THE ACCESSORY CHANNEL OF THE ENDOSCOPE. THE DEPLOYMENT BUTTON WAS PRESSED AND A SMALL BIT OF POWDER EXITED. THE SECOND CATHETER WAS ALSO USED. THE PHYSICIAN'S INITIAL ASSESSMENT WAS THAT THE CATHETER KINKED. CLIPS AND A BIPOLAR PROBE WERE USED TO FINISH THE PROCEDURE. OTHER THAN THE DEPLOYED HEMOSPRAY, THE INFORMATION PROVIDED DOES NOT SUGGEST A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. IT WAS REPORTED THAT THERE WAS NO COMPLICATION. WE CAN CONCLUDE THAT THIS INFORMATION DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152598 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY G56572 W4372104 00827002565722

    Patients

    Seq Age Sex Outcome Treatment
    1