BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG., AGG. PLUS SHAVER BLADE

    MDR report key: 1804312 · Received February 5, 2010

    Report

    Report Number
    2936485-2009-00440
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    March 13, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 UNDER (B)(4). THERE ARE 1 EVENT(S) ASSOCIATED WITH THIS EVENT TYPE (MALFUNCTION) AND PRODUCT CODE GFF.

    Description of Event or Problem · 1

    METAL SHAVINGS. "METAL SHAVINGS ENDED UP IN THE SHOULDER. THIS HAPPENED TO 2 BLADES. THEY WERE ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY AND NO FOLLOW-UP SURGERY SHOULD BE REQUIRED. THEY WERE ABLE TO GET THE SHAVINGS OUT OF THE SHOULDER AND THE PT WAS NOT INJURED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKG., AGG. PLUS SHAVER BLADE INSTRUMENT HRX STRYKER ENDOSCOPY SAN JOSE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA