BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILS 29MM CURVED

    MDR report key: 3533927 · Received December 23, 2013

    Report

    Report Number
    3005075853-2013-07123
    Event Type
    Malfunction
    Date Received
    December 23, 2013
    Date of Event
    December 2, 2013
    Report Date
    December 2, 2013
    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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT 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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LADG PROCEDURE, AFTER TRANSACTION, THE SURGEON INTRODUCED DEVICE TO ANASTOMOSE G-J. HE SAID HE DID USE DEVICE AS USUAL, BUT HE FOUND INCOMPLETE TISSUE DONUT AFTER FIRING. ANTERIOR PORTION OF STAPLE LINE WAS FORMED WELL, BUT POSTERIOR PORTION OF STAPLE LINE WAS NOT FORMED. SURGEON REINFORCED STAPLE LINE MANUALLY AFTER REMOVING DEVICE FROM THE PATIENT. THE PATIENT IS WELL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673239 ILS 29MM CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4CN66

    Patients

    Seq Age Sex Outcome Treatment
    1