BEUDAMED
    FDA Adverse Event Summary report: N

    CODMAN CLASSIC PLUS

    MDR report key: 2971596 · Received February 13, 2013

    Report

    Report Number
    2971596
    Date Received
    February 13, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 13, 2013
    Manufacturer
    SYMMETRY SURGICAL (CODMAN)
    Product Code
    HFB
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    AT THE END OF THE SURGICAL PROCEDURE, IT WAS NOTED THAT PART OF THE INSIDE JAW OF A NEEDLE HOLDER WAS MISSING. IT IS UNKNOWN WHETHER OR NOT IT WAS INTACT AT THE BEGINNING OF THE CASE. THE PHYSICIAN WAS NOTIFIED. AN ABDOMINAL X-RAY WAS TAKEN AND READ AS NEGATIVE BY THE RADIOLOGIST AS "NO FOREIGN BODY SEEN".WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PERITONEAL DIALYSIS CATHETER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64242 CODMAN CLASSIC PLUS BIOPSY NEEDLE KIT HFB SYMMETRY SURGICAL (CODMAN) 363001 SN 9104N

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR