BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROXIMATE PROXIMATE I L S CURVED INTRALUMINAL STAPLE

    MDR report key: 378979 · Received February 25, 2002

    Report

    Report Number
    1527736-2002-00276
    Event Type
    Death
    Date Received
    February 25, 2002
    Report Date
    January 25, 2002
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    GAG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE WAS USED DURING AN ESOPHAGOGASTRIC ANASTOMOSIS. THE DEVICE WAS USED WITHOUT INCIDENCE. THREE DAYS POST OP PATIENT WAS RETURNED TO SURGERY DUE TO THE STAPLE LINE GIVING WAY. PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE PROXIMATE I L S CURVED INTRALUMINAL STAPLE PROXIMATE ILS CIRCULAR STAPLERS GAG ETHICON ENDO-SURGERY - ALB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death