BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ETS

    MDR report key: 316185 · Received February 15, 2001

    Report

    Report Number
    1527736-2001-00704
    Event Type
    Injury
    Date Received
    February 15, 2001
    Date of Event
    January 22, 2001
    Report Date
    January 22, 2001
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    KOG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) TSB45 AND (5) TR45B WERE USED DURING A VATS PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE WOULD NOT STAPLE BUT CUT FROM THE SECOND FIRING TO THE SIXTH FIRING. THE CASE WAS CONVERTED TO OPEN SINCE THE SURGEON COULD NOT REPAIR THE TISSUE. THERE WAS NO CONSEQUENCE TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5898 ENDOPATH ETS LINEAR CUTTERS - ENDOSCOPIC KOG ETHICON ENDO-SURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention