BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** SKIN STAPLER 35 WIDE

    MDR report key: 2202690 · Received August 11, 2011

    Report

    Report Number
    3005075853-2011-03258
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 19, 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
    OH, 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.

    Additional Manufacturer Narrative · 1

    (B)(4): TEAM FROM EES MET WITH CERTIFIED SURGICAL ASSISTANT (CSA) AT ACCOUNT ON (B)(4) 2011: CSA NOTED THAT AS THE FIRING TRIGGER WAS BEING PULLED TO FORM THE STAPLES HE WOULD NOTICE A SNAP SOUND AND THAT THE FIRING TRIGGER WOULD HAVE NO CLOSING RESISTANCE. HE NOTED THAT THIS WOULD OCCUR APPROXIMATELY HALF WAY THROUGH THE FIRING STROKE. HE ALSO STATED THE STAPLE FORM WAS STRAIGHT WITH THE POINTS STICKING DOWN. HE SAID THAT THE STAPLES OCCASIONALLY STUCK IN THE DEVICE BUT FOR THE MOST PART THEY WOULD BE BARELY INTO THE TISSUE AND ANY LATERAL MOVEMENT OF THE TISSUE WOULD POP THE STAPLE OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A C-SECTION PROCEDURE, THE STAPLES WERE NOT FORMING; THEY WERE NOT HOLDING THE SKIN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. THE DEVICE WAS 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 H43Y5H

    Patients

    Seq Age Sex Outcome Treatment
    1