BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG LIGHT PIPE

    MDR report key: 2063143 · Received March 22, 2011

    Report

    Report Number
    1822565-2011-00710
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    FST
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE LIGHT PIPES MAY WEAR AND FRACTURE DURING USE. FRACTURES HAVE BEEN REPORTED AT THE PLASTIC TAB, PLASTIC PRONGS, AND STAINLESS STEEL PIPE. THESE SITUATIONS MAY BE A RESULT OF (BUT ARE NOT LIMITED TO): EXCESSIVE AND/OR IMPROPER BENDING OR MANIPULATING OF THE LIGHT PIPES WHILE ATTACHED TO THE RETRACTOR; NORMAL WEAR AND TEAR; IMPROPER USE OF THE INSTRUMENT; AND/OR ACCIDENTAL DROP OR CONTACT WITH HARD SURFACE. A DEFINITIVE CAUSE FOR THIS EVENT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: NO MANUFACTURING ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PLASTIC PIECES FRACTURED OFF THE LIGHT PIPE WHEN IT WAS REMOVED FROM THE RETRACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG LIGHT PIPE FST ZIMMER, INC. 60175726

    Patients

    Seq Age Sex Outcome Treatment
    1