BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR CUTTER

    MDR report key: 150257 · Received February 19, 1998

    Report

    Report Number
    1527736-1998-00441
    Event Type
    Malfunction
    Date Received
    February 19, 1998
    Date of Event
    January 23, 1998
    Report Date
    January 23, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.49010. EES #.980626/A. D5,6; H4: INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TLC55 WAS USED DURING A TOTAL GASTRECTOMY. IT WAS REPORTED BY THE AFFILIATE SOME OF THE STAPLES (2-3 BEGINNING OF STAPLE LINE) WERE MALFORMED. THE SURGEON PUT SOME STITCHES TO CLOSE THE TISSUE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE LINEAR CUTTER LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other