BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLSEN BIPOLAR

    MDR report key: 7652421 · Received June 29, 2018

    Report

    Report Number
    3007208013-2018-00009
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    March 7, 2018
    Report Date
    June 27, 2018
    Manufacturer
    OLSEN MEDICAL LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBER ASSIGNED BY US FDA Z-1941-2018, Z-1942-2018, Z-1945-2018, Z1944-2018, Z-1943-2018.

    Description of Event or Problem · 1

    SYMMETRY SURGICAL INITIATED A RECALL ACTION, WE DID SEND THE 806 FORM TO FDA AND HAVE STARTED THIS RECALL ACTION. THIS RECALL HAS BEEN INITIATED AS A RESULT OF SYMMETRY SURGICAL, INC. ("SYMMETRY SURGICAL") BECOMING AWARE THAT THE SOME OF THE PRODUCTS MAY ENCROACH INTO THE STERILE POUCH SEAL THEREBY INCREASING THE RISK OF THE SEAL BEING COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492371 OLSEN BIPOLAR BIPOLAR FORCEP, CORD GEI OLSEN MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1