BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS SMALL ACCESS RETRACTOR

    MDR report key: 1003662 · Received February 14, 2008

    Report

    Report Number
    3005075853-2008-00020
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 23, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K070198
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PROCEDURE, WHILE IN THE PACKAGE, IT WAS NOTICED THAT THE PLASTIC HAD PULLED AWAY FROM THE RIM OF THE DEVICE. NOT INVOLVED IN A PROCEDURE. DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS SMALL ACCESS RETRACTOR GCJ ETHICON ENDO-SURGERY, LLC NA D4JM18

    Patients

    Seq Age Sex Outcome Treatment
    1