BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ARTICULATING LINEAR CUTTER

    MDR report key: 317003 · Received February 20, 2001

    Report

    Report Number
    1527736-2001-00759
    Event Type
    Malfunction
    Date Received
    February 20, 2001
    Date of Event
    January 22, 2000
    Report Date
    January 23, 2001
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GCJ
    Removal / Correction Number
    NA
    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) ATB45 WAS USED DURING A VIDEO ASSISTED THORACIC SURGERY LOBECTOMY PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE WOULD NOT FIRE AND FIRING KNOB BROKE. OPENED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6494 ENDOPATH ARTICULATING LINEAR CUTTER LINEAR CUTTERS - CONVENTIONAL GCJ ETHICON ENDO-SURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other