BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE I L S INTRALUMINAL STAPLER

    MDR report key: 350531 · Received September 7, 2001

    Report

    Report Number
    1527736-2001-04733
    Event Type
    Injury
    Date Received
    September 7, 2001
    Date of Event
    July 31, 2001
    Report Date
    August 8, 2001
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    GAG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING AN ANTERIOR RESECTION. WHEN THE DEVICE WAS FIRED, THE STAPLES WERE JAMMED ALONG WITH THE TISSUE IN THE ANVIL. THE TISSUE WAS TORN TO RELEASE IT FROM THE DEVICE. THE PATIENT WAS HANDSEWN AND A COLOSTOMY (LOOP) WAS PERFORMED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40593 PROXIMATE I L S INTRALUMINAL STAPLER CIRCULAR STAPLERS GAG ETHICON ENDO-SURGERY - ALB NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention