BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED 60 ECHELON +, 440MM SHAFT

    MDR report key: 12514035 · Received September 22, 2021

    Report

    Report Number
    3005075853-2021-05653
    Event Type
    Injury
    Date Received
    September 22, 2021
    Date of Event
    January 1, 2021
    Report Date
    September 1, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014614
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXACT EVENT DATE UNKNOWN, ONLY EVENT YEAR: 2021. BATCH # UNK. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. AN EVALUATION OF THE MANUFACTURING DOCUMENTATION COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WAS ANY SURGICAL INTERVENTION REQUIRED FOR THE CASE? I WAS TOLD THAT HE PUT THEM NPO WITH TPN. THE PATIENT HAD A STENT FOR A CERTAIN AMOUNT OF TIME FOLLOWED UP WITH TPN NPO. COULD YOU PLEASE CLARIFY IF WAS ANY CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? STENTS FOR A TIME FOLLOWED UP WITH TPN NPO. COULD YOU PLEASE CLARIFY WHAT IS THEIR CURRENT PATIENT STATUS? WILL HAVE TO CONFIRM WITH SURGEON: THE CURRENT PATIENT, HE THINKS MAY HAVE HEMATOMA INSTEAD OF LEAK. HE IS GOING TO LOOK TODAY. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS A LEAK TEST PERFORMED? IF SO, WHAT TYPE AND WHAT WAS THE RESULT? A LEAK TEST WAS PERFORMED. THERE WAS NO LEAK. WAS THE STAPLE LINE VISUALIZED ENDOSCOPICALLY DURING THE INITIAL SURGICAL PROCEDURE? STAPLE LINE WAS VISUALIZED. HOW MANY DAYS POSTOPERATIVE DID THE LEAK OCCUR? IT WAS DISCOVERED 30 DAYS POST OP. HOW WAS THE LEAK IDENTIFIED? IT WAS IDENTIFIED VIA UNKNOWN. WHAT WAS OBSERVED AT THE SITE OF THE LEAK UPON REOPERATION? THERE WAS NO REOPERATION. HOW WAS THE LEAK ADDRESSED? A STENT WAS PLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OPERATIVE AFTER A LAPAROSCOPIC SLEEVE GASTRECTOMY A PATIENT DEVELOPED A LEAK. THE PATIENT RECEIVED A STENT. THERE IS NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409473 POWERED 60 ECHELON +, 440MM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PLEE60A 10705036014614

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GST60G| GST60T