BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROXIMATE I L S CURVED INTRALUMINAL STAPLER

    MDR report key: 385261 · Received March 28, 2002

    Report

    Report Number
    1527736-2002-00607
    Event Type
    Death
    Date Received
    March 28, 2002
    Date of Event
    February 27, 2002
    Report Date
    February 27, 2002
    Manufacturer
    ETHICON ENDO-SURGERY-ALB
    Product Code
    GAG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE DEVICE WAS USED DURING A ANTERIOR RESECTION, THE STAPLES DID NOT FIRE CORRECTLY. HAND SEWING WAS PERFORMED TO CLOSE THE SITE. A COLOSTOMY WAS PERFORMED TO ALLOW THE SITE TO HEAL. THE PATIENT LATER EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE I L S CURVED INTRALUMINAL STAPLER PROXIMATE ILS CIRCULAR STAPLERS GAG ETHICON ENDO-SURGERY-ALB NA 276-R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death