BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH ETS

    MDR report key: 276223 · Received May 3, 2000

    Report

    Report Number
    1527736-2000-01799
    Event Type
    Death
    Date Received
    May 3, 2000
    Report Date
    April 5, 2000
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    KOG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS PHONED IN BY THE REP THAT A TSG45 WAS USED DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE WITH ROUX-EN-Y. IT WAS REPORTED THAT THE STAPLE LINE LEAKED AND DEHISCED. THE PT HAS EXPIRED. THERE ARE MORE DETAILS TO FOLLOW.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| O