BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** SKIN STAPLER 35 WIDE

    MDR report key: 2221427 · Received August 24, 2011

    Report

    Report Number
    3005075853-2011-03472
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDT
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THERE WAS A PACKAGING LOT OR BATCH NUMBER PROVIDED BY THE USER FACILITY. WITH THIS INFORMATION, THE MANUFACTURING RELATED RECORDS WERE REVIEWED AND WE WERE UNABLE TO CONFIRM THE COMPLAINT NOR DETERMINE A MANUFACTURING OR DESIGN RELATED CAUSE FOR THE REPORTED EVENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLASTIC SURGERY PROCEDURE, THE DEVICE FIRED AND THE STAPLES WERE MALFORMED. THE LEGS WERE NOT CLOSING TO FORM THE STAPLE. A SECOND DEVICE WAS PULLED AND THE SAME THING OCCURRED. A THIRD DEVICE WAS PULLED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. BOTH DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** SKIN STAPLER 35 WIDE SKIN STAPLER GDT ETHICON ENDO-SURGERY, LLC. NA H43X2J

    Patients

    Seq Age Sex Outcome Treatment
    1