BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12K HAND CONTROL SHAVER HANDPIECE

    MDR report key: 1621836 · Received February 5, 2010

    Report

    Report Number
    2936485-2009-00432
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    August 23, 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 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 EXEMPTION (B) (4). THERE ARE 2 EVENT(S) ASSOCIATED WITH THIS EVENT TYPE (MALFUNCTION) AND (B) (4).

    Description of Event or Problem · 1

    WATER INGRESS. PLEASE ADD (B) (4)...CORD IS LOOSE...MOISTURE IS GETTING INSIDE SHAVER...(B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12K HAND CONTROL SHAVER HANDPIECE INSTRUMENT HRX STRYKER ENDOSCOPY SAN JOSE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA