BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEEDLE HOLDER, CODMAN ,CLASSIC PLUS

    MDR report key: 2536270 · Received April 4, 2012

    Report

    Report Number
    2536270
    Event Type
    Other
    Date Received
    April 4, 2012
    Date of Event
    January 16, 2012
    Report Date
    April 4, 2012
    Manufacturer
    SYMMETRY SURGICAL (CODMAN)
    Product Code
    FCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE NEEDLE DRIVER CAME OFF WHILE THE DEVICE WAS IN USE. THIS WAS NOT IDENTIFIED DURING THE OPERATION. THE RETAINED FOREIGN BODY (RFB) WAS SEEN ON ROUTINE POST-OP IMAGING. THE PATIENT REQUIRED A SECOND SURGERY UNDER GENERAL ANESTHESIA TO REMOVE RFB. THE MFR RESPONSE FOLLOWS FOR THE NEEDLE DRIVER, CODMAN CLASSIC PLUS NEEDLE HOLDER # 36-3011. THE MFR HAVE OPENED A QUALITY CONCERN AND A MEETING IS BEING SCHEDULED TO REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEEDLE HOLDER, CODMAN ,CLASSIC PLUS NEEDLE DRIVER FCG SYMMETRY SURGICAL (CODMAN) NEEDLE HOLDER, CODMAN CLASSIC PLUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other