BEUDAMED
    FDA Adverse Event Summary report: N

    ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTER RELOAD UNIT

    MDR report key: 369908 · Received December 12, 2001

    Report

    Report Number
    1527736-2001-06215
    Date Received
    December 12, 2001
    Date of Event
    August 16, 2001
    Report Date
    December 4, 2001
    Manufacturer
    *
    Product Code
    KOG
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE CUSTOMER(CUSTOMER MEDWATCH #490118-2001-30),THAT THE ZR45 CARTRIDGE ONLY FIRED ONE SIDE OF STAPLES. IT REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55954 ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTER RELOAD UNIT LINEAR CUTTERS - ENDOSCOPIC KOG * NA *

    Patients

    Seq Age Sex Outcome Treatment
    1