BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 9787885 · Received March 4, 2020

    Report

    Report Number
    1037905-2020-00120
    Event Type
    Malfunction
    Date Received
    March 4, 2020
    Report Date
    February 6, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE 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

    DURING A HEMOSTASIS PROCEDURE, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. AA RESULT OF RECEIVING THE CUSTOMER NOTIFICATION FOR RECALL 057-R, IT WAS REPORTED THAT A TECHNICIAN STATED THAT AT "SOME POINT", THEY HAD A HEMOSPRAY HANDLE CRACK. NO OTHER INFORMATION WAS GIVEN ABOUT THE PROCEDURE OR WHEN IT HAPPENED. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED. THIS COMPLAINT WAS A RESPONSE TO THE RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253261 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1