BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)

    MDR report key: 1951253 · Received December 13, 2010

    Report

    Report Number
    2648666-2010-00482
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 17, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STRYKER TWO 4.0MM AGGRESSIVE PLUS CUTTER FAILED, BOTH TIMES, DURING A PT'S PROCEDURE. IT WAS ALLEGED THAT IN BOTH INCIDENTS, THE INNER SHEATH SPUN OUT OF ALIGNMENT WITH THE OUTER SHEATH CAUSING THE TIP OF THE BLADE TO BEND. ANOTHER BLADE WAS AVAILABLE FOR USE. IT IS UNK WHETHER THE PROCEDURE WAS COMPLETED SUCCESSFULLY OR IF THERE WERE ANY ADVERSE CONSEQUENCES TO THE PT. HOWEVER, AT THIS TIME, THERE ARE NO REPORTS OF ANY ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) CUTTER HRX STRYKER ENDOSCOPY PUERTO RICO 10266CE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK