BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7FR FIXEDPIN HEMOSTATIC PROBE

    MDR report key: 10468659 · Received August 28, 2020

    Report

    Report Number
    3005975494-2020-00019
    Event Type
    Injury
    Date Received
    August 28, 2020
    Date of Event
    March 16, 2020
    Report Date
    August 28, 2020
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    KNS
    PMA / PMN Number
    K123319
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. PER THE CUSTOMER, IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED BACK FOR EVALUATION SINCE IT IS IN THE BIO-HAZARD CONTAINER AND MAY HAVE BEEN THROWN OUT. SUBSEQUENTLY, THE CUSTOMER HAS BEEN UNRESPONSIVE TO REQUESTS FOR FOLLOW UP. FOR THIS REASON A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF THE DEVICE, OR ADDITIONAL INFORMATION, BECOMES AVAILABLE AT A LATER DATE THE COMPLAINT WILL BE UPDATED ACCORDINGLY. BASED UPON REVIEW OF PRODUCTION RECORDS THERE APPEARS TO BE NO INDICATION THAT MANUFACTURING CONTRIBUTED TO THE REPORTED FAILURE AS ALL DEVICES MET FINAL ACCEPTANCE CRITERIA PRIOR TO RELEASE. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE THROUGH REGULAR TRENDING ACTIVITIES AS DEFINED BY OLYMPUS SURGICAL TECHNOLOGIES AMERICA QUALITY MANAGEMENT SYSTEM PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN EMERGENT PROCEDURE WHILE ATTEMPTING TO CAUTERIZE AN GASTROINTESTINAL ARTERIOVENOUS MALFORMATION (AVM), THE PROBE DID NOT HEAT UP. AS A RESULT, THERE WAS A DELAY IN CAUTERIZING THE AVM. THE CLINICIAN WAS REQUIRED TO USE A HOT SNARE TO CAUTERIZE THE AVM AND COMPLETE THE PROCEDURE. OTHER THAN THE DELAY IN THE PROCEDURE, NO OTHER PATIENT IMPACT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933398 7FR FIXEDPIN HEMOSTATIC PROBE HEMOSTASIS PROBE KNS GYRUS ACMI, INC CD-B622LA KR869055

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention