BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3905235 · Received July 1, 2014

    Report

    Report Number
    3005075853-2014-04535
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION BUT A PHOTOGRAPH OF THE STAPLE LINE WAS PROVIDED FOR ANALYSIS. PHOTOGRAPH. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT TYPE OF BUTTRESSING WAS USED? PATIENT BMI. PATIENT GENDER? WHAT COLOR CARTRIDGE FOR THE FIRST FIRING? WAS PULSING USED IF A POWERED DEVICE WAS USED? CONCLUSION: BASED ON THE PHOTOGRAPHIC EVIDENCE OF THE SUBJECT ECR60G CARTRIDGE, UNFORMED STAPLES CAN BE CONFIRMED, HOWEVER, THE PHOTOGRAPH DOES NOT PROVIDE EVIDENCE RELATIVE TO WHAT MAY HAVE CAUSED THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC SLEEVE PROCEDURE, ON THE SECOND FIRING WITH A GREEN CARTRIDGE THE REMNANT SIDE OF THE STAPLE LINE WAS FORMED AND INTACT. THE PATIENT SIDE HAD ONLY ONE STAPLE LINE FORMED AND THE OTHER TWO STAPLE LINES WERE NOT. THERE WAS SIGNIFICANT BLEEDING ON THE STOMACH. THE SURGEON EMBROCATED THE STAPLE LINE AND OVER SEWED IT TO CONTROL THE BLEEDING. AS A RESULT, THE PATIENT REMAINED IN THE HOSPITAL ONE DAY LONGER THAN ANTICIPATED. THERE WAS NO ISSUE WITH FIRING THE DEVICE. THE SURGEON WAITED THE 15 SECONDS PRIOR TO FIRING. THEY CLEANED/SWISHED THE JAWS OF THE DEVICE BEFORE LOADING A NEW CARTRIDGE INTO THE JAWS. THE CARTRIDGE AND DEVICE WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382708 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 DEVICE - PLE60A