BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRSTPASS NEEDLE AND SUTURE CAPTURE

    MDR report key: 2331844 · Received October 21, 2011

    Report

    Report Number
    2032380-2011-00127
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    January 1, 2011
    Report Date
    October 3, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S AGE AND GENDER HAVE BEEN REQUESTED BUT NOT RECEIVED. REFERENCE MFR'S REPORT # 2032380-2011-00125, 2032380-2011-00126, 2032380-2011-00128.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY USING THE FIRSTPASS SUTURE PASSER THE INSTRUMENT WOULD NOT PROPERLY LOAD THE FIRSTPASS NEEDLE AND SUTURE CAPTURE. THE PHYSICIAN ATTEMPTED TO LOAD THREE DIFFERENT FIRSTPASS NEEDLE AND SUTURE CAPTURES DURING THE PROCEDURE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRSTPASS NEEDLE AND SUTURE CAPTURE NEEDLE, SUTURING, DISPOSABLE LXH ARTHROCARE CORP. 1016208

    Patients

    Seq Age Sex Outcome Treatment
    1 Other