BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA

    MDR report key: 8746594 · Received June 28, 2019

    Report

    Report Number
    1219930-2019-03822
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    June 6, 2019
    Report Date
    August 13, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884523002867
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF TWO PHOTOS OF STAPLE FORMATION ISSUES. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH REGARD TO THE REPORTED CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN CUTTING THE STOMACH FUNDUS THERE WAS POOR STAPLE FORMATION FOR BOTH RELOAD USED. THE SURGEON HAD TO RE-SUTURE THE STOMACH WITH MANUAL SUTURE CAUSING A 30 MINUTES SURGICAL TIME EXTENSION. THERE WAS TISSUE DAMAGE DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540063 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN 030455 10884523002867

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention