BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM RESECTOR CUTTER, FORMULA (5BX)

    MDR report key: 1664469 · Received March 23, 2010

    Report

    Report Number
    2648666-2010-00175
    Event Type
    Malfunction
    Date Received
    March 23, 2010
    Date of Event
    March 23, 2010
    Report Date
    March 23, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    FZT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE CUTTER LEFT A NON SPECIFIED MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM RESECTOR CUTTER, FORMULA (5BX) CUTTER FZT STRYKER ENDOSCOPY PUERTO RICO 08135CE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK