BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 9801678 · Received March 6, 2020

    Report

    Report Number
    1037905-2020-00127
    Event Type
    Malfunction
    Date Received
    March 6, 2020
    Report Date
    February 11, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: NOT AVAILABLE. REGULATION NAME: HEMOSTATIC DEVICE FOR INTRALUMINAL GASTROINTESTINAL USE PRODUCT CODE: QAU. PMA/510K: 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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: A CORRECTIVE ACTION HAS BEEN INITIATED TO REDUCE OCCURRENCES OF ACTIVATION KNOB AND HANDLE BREAKAGE OR CRACKING. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION 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

    PRIOR TO AN ENDOSCOPIC PROCEDURE TO TREAT A GASTROINTESTINAL BLEED, THE PHYSICIAN SELECTED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. AS THE DEVICE WAS PRIMED, BEFORE IT WAS FULLY TIGHTENED, THE CARTRIDGE BROKE OUT OF THE HANDLE (RED PLASTIC AT THE BOTTOM ). THERE WAS NO INJURY TO THE STAFF OR PATIENT, OR DAMAGE TO THE ROOM OR EQUIPMENT. ANOTHER DEVICE [HEMOSPRAY] WAS USED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. THE USER SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260128 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1