BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM

    MDR report key: 3093549 · Received May 6, 2013

    Report

    Report Number
    3005075853-2013-02134
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. PHOTO ANALYSIS. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, AN INVESTIGATION COULD NOT BE PERFORMED. WE DID NOT RECEIVE A BATCH NUMBER OR LOT NUMBER SO THEREFORE WE WERE UNABLE TO REVIEW THE MANUFACTURING RECORDS. INTRA OPERATIVE PHOTOGRAPHS WERE RECEIVED. UPON REVIEW OF THE IMAGES, IT WAS CONCLUDED THAT THE POTENTIAL CAUSE OF THE REPORTED EVENT WAS THE RESULT OF THE FATTY TISSUE AREA BEING TOO THICK FOR THE GREEN CARTRIDGE SELECTED. ADDITIONALLY THE MIDLINE OPEN FORMED STAPLES ARE POSSIBLY THE RESULT OF THE DEVICE NOT BEING ABLE TO COMPRESS THE TISSUE TO THE SPECIFIED THICKNESS WITHOUT THE STAPLE CARTRIDGE DECK DEFLECTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, SURGEON REPORTED THAT STAPLES DID NOT FORM CORRECTLY DURING THE FIRST FIRING (GREEN LOAD). HE STATED THE STAPLES WERE "CRISS CROSSED" AND THAT MANY OF THE MOST LATERAL STAPLES DID NOT FORM AT ALL. HE ALSO REPORTED THAT THE STAPLER DID NOT FEEL SMOOTH ON THE INITIAL FIRING, BUT SEEMED TO FUNCTION WELL ON THE SUBSEQUENT FIRINGS. SURGEON USED AN OVERSEW TECHNIQUE ON THE AFFECTED STAPLE LINE. COMPLETED THE CASE USING BLUE RELOADS (HIS NORMAL TECHNIQUE) ON ALL SUBSEQUENT GASTRIC FIRINGS. HE UTILIZED THE INITIAL STAPLER FOR THESE LOADS AS WELL WITH NO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196901 ECHELON*FLEX60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G- UNKNOWN