BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO LINEAR CUTTERS-ETS45MM

    MDR report key: 725956 · Received June 8, 2006

    Report

    Report Number
    1527736-2006-02612
    Event Type
    Malfunction
    Date Received
    June 8, 2006
    Date of Event
    March 3, 2006
    Report Date
    March 6, 2006
    Manufacturer
    ETHICON ENDO-SURGERY, INC.(CINCINNATI)
    Product Code
    KOG
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: BASED ON THE ANALYSIS FINDING OF DAMAGED PINION AXLE SUPPORT, THIS FILE IS CONSIDERED TO BE REPORTABLE. THE DEVICE WAS RETURNED WITH THE FIRING MECHANISM DAMAGED AND WITH NO CARTRIDGE PRESENT. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS; THE LEFT SHROUD PINION AXLE SUPPORT WAS FOUND DAMAGED, NO FUNCTIONAL TEST WAS PERFORMED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT, AS THERE WAS NO CARTRIDGE RETURNED FOR ANALYSIS. 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

    DURING A GASTRIC BYPASS PROCEDURE THE DEVICE WOULD NOT FIRE, THE STAPLES WERE PROTRUDING OUT OF THE RELOAD CARTRIDGE. THERE WAS NO PT CONSEQUENCE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO LINEAR CUTTERS-ETS45MM GDW KOG ETHICON ENDO-SURGERY, INC.(CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN