BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE RELOADABLE LINEAR STAPLER

    MDR report key: 149363 · Received February 16, 1998

    Report

    Report Number
    1527736-1998-00390
    Event Type
    Injury
    Date Received
    February 16, 1998
    Report Date
    January 19, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.48850. EES #.980492-1. D9; H2,3,6; G4: ADDED ADDITION INFO. D5; H4: INFO NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. D6: CORRECTED FIELD TO READ NA.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER A LOW ANTERIOR RESECTION WITHOUT INCIDENT, THE PT WAS BROUGHT BACK TO SURGERY 2 WEEKS POST OP FOR A LEAKING STAPLE LINE. THE LEAKING AREA WAS APPROX 3MM. THE TWO STAPLERS USED WERE TX60G AND TLC55. TWO TCR55 RELOADS WERE USED IN THE TLC55. THE REP HAD NO FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR STAPLER RELOADABLE LINEAR STAPLER GAG ETHICON ENDO-SURGERY, INC. NA K46L24

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R