BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS 45 ENDO LINEAR CUTTER BL

    MDR report key: 655661 · Received December 19, 2005

    Report

    Report Number
    1527736-2005-06205
    Event Type
    Malfunction
    Date Received
    December 19, 2005
    Report Date
    December 14, 2005
    Manufacturer
    ETHICON ENDO-SURGERY, INC.(CINCINNATI)
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: TWO DEVICES WERE RECEIVED. DEVICE A WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITH OUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. DEVICE B WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD CARTRIDGE LOADED IN THE INSTRUMENT. THE CARTRIDGE WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS. 510(K) # IS K020779.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DEVICE CUT BUT DID NOT STAPLE. THE PROCEDURE WAS COMPLETED BY HAND-SUTURING. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS 45 ENDO LINEAR CUTTER BL ENDO LINEAR CUTTERS - ETS45MM KOG ETHICON ENDO-SURGERY, INC.(CINCINNATI) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN