BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG., EGG BUR, 8 FLUTE - 5.0M

    MDR report key: 1621943 · Received February 5, 2010

    Report

    Report Number
    2648666-2009-00392
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    August 22, 2006
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    HRX
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN, STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE BEING SUBMITTED (B) (4). THERE ARE 22 EVENT(S) ASSOCIATED WITH THIS EVENT TYPE (MALFUNCTION) AND PRODUCT CODE GFF.

    Description of Event or Problem · 1

    BROKE/FLAKING. "IT WAS REPORTED THAT THE BUR WAS FLAKING METAL SHAVINGS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKG., EGG BUR, 8 FLUTE - 5.0M INSTRUMENT HRX STRYKER ENDOSCOPY PUERTO RICO NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA