BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPUS SMARTSTITCH M-CONNECTOR

    MDR report key: 2093862 · Received April 22, 2011

    Report

    Report Number
    2032380-2011-00041
    Event Type
    Other
    Date Received
    April 22, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K022229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S AGE WAS REQUESTED, BUT TO DATE HAS NOT BEEN PROVIDED. THE DATE OF THE EVENT WAS REQUESTED, BUT TO DATE HAS NOT BEEN PROVIDED, THEREFORE, AN APPROXIMATE MONTH AND YEAR WERE NOTED. THE INVESTIGATION IS CURRENTLY IN PROGRESS. A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO ARTHROCARE ON (B)(6) 2011 THAT A PT UNDERWENT A PROCEDURE, USING AN OPUS SMARTSTITCH M-CONNECTOR. ALLEGEDLY, THE M-CONNECTOR BROKE COMPLETELY IN HALF DURING THE SURGERY. THE SURGERY WAS DELAYED BY MORE THAN 30 MINUTES. THE PHYSICIAN REVERTED TO A MINI OPEN TO COMPLETE THE SURGERY. NO ADVERSE REACTIONS TO THE PT AND NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPUS SMARTSTITCH M-CONNECTOR ENDOSCOPE AND ACCESSORIES KOG ARTHROCARE CORPORATION 1010632

    Patients

    Seq Age Sex Outcome Treatment
    1 Other