BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISP. TA LONG 90-4.8 TITANIUM STAPLER

    MDR report key: 391916 · Received April 29, 2002

    Report

    Report Number
    2647580-2002-00071
    Event Type
    Injury
    Date Received
    April 29, 2002
    Date of Event
    March 6, 2002
    Report Date
    March 27, 2002
    Manufacturer
    PONCE -USS
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE SURGEON COMPLETED THE PROCEDURE AS NORMAL, EVERYTHING, INCLUDING VISUALIZATION LOOKED GOOD. THE PT WAS RUNNING A SLIGHT FEVER, POST-OPERATIVELY. THE PT WAS DISCHARGED (NO DATE). THE PT STARTED EXPERIENCING SOME DIFFICULTIES AND WENT INTO THE EMERGENCY ROOM ON OR ABOUT 03/2002. THE SURGEON PERFORMED AN EMERGENCY THORACOTOMY, IT WAS REPORTED THAT THE STAPLE LINE HAD COMPLETELY DEHISCED. THE SURGEON REMOVED THE SPECIMEN THEN PERFORMED THE PROCEDURE AGAIN. THE ORIGINAL STAPLE LINE WAS REMOVED AND X-RAY SHOWED POORLY FORMED STAPLES. THE SURGEON RECALLS HEARING THE CLICK, BUT DOES NOT KNOW WHETHER THE BLACK INDICATOR LINE WAS FULLY SEATED ON THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISP. TA LONG 90-4.8 TITANIUM STAPLER DISPOSABLE SURGICAL STAPLER GAG PONCE -USS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other