BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILS 29MM, STRAIGHT

    MDR report key: 2896883 · Received January 4, 2013

    Report

    Report Number
    3005075853-2013-00050
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    December 12, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITHOUT STAPLES PRESENT. THE BREAKAWAY WASHER WAS NOT RECEIVED. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. THE DEVICE FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS THAT DURING A LAPAROSCOPIC SIGMOID PROCEDURE, THERE WAS AN INCOMPLETE STAPLE LINE. TO COMPLETE THE PROCEDURE THEY SUTURED BY HAND. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4955 ILS 29MM, STRAIGHT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CD03

    Patients

    Seq Age Sex Outcome Treatment
    1