BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS FLEX45

    MDR report key: 3012414 · Received March 20, 2013

    Report

    Report Number
    3005075853-2013-01312
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCOMPLETE-INTERRUPTED CYCLE, DAMAGED CARTRIDGE THE ANALYSIS RESULTS SHOWED THAT TWO RELOADS WERE RECEIVED WITHOUT AN INSTRUMENT. RELOAD (A) WAS RECEIVED PARTIALLY FIRED AND WITH THE LOCKOUT SPRING NORMAL. THE RELOAD PARTIALLY FIRED INDICATES THAT THE DEVICE'S FIRING CYCLE WAS INTERRUPTED. WHEN FIRING THE DEVICE MAKE SURE THAT THE FIRING STROKE IS COMPLETED. DO NOT PARTIALLY FIRE THE DEVICE. FIRE THE DEVICE BY SQUEEZING THE FIRING TRIGGER COMPLETELY UNTIL IT RESTS ON THE CLOSING TRIGGER. ONCE THE FIRING CYCLE HAS BEEN INITIATED, IT MUST BE COMPLETED. IF RE-INITIATION OF FIRING IS RESUMED, THE DEVICE WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE RELOAD (B) WAS RECEIVED PARTIALLY FIRED, WITH THE CARTRIDGE DECK DAMAGED, AND THE LOCKOUT SPRING NORMAL; THE CARTRIDGE DECK WAS DAMAGED WHERE THE FIRING STOPPED. THE DAMAGE TO THE CARTRIDGE IS CONSISTENT WITH THE DEVICE BEING CLAMPED OVER A HARD OBJECT. WHEN THIS HAPPENS THE CARTRIDGE GETS INDENTED THEREFORE THERE IS NOT ENOUGH SPACE FOR THE WEDGES PUSHING THE DRIVER TO CONTINUE ITS RUN. IF ENOUGH FORCE IS APPLIED TO THE FIRING TRIGGER THE WEDGES CAN BREAK THROUGH THE CARTRIDGE RELOAD WALL ALLOWING THE FIRING TO CONTINUE. WHEN PLACING THE INSTRUMENT ON THE TISSUE TO BE STAPLED, ENSURE THAT NO HARD OBSTRUCTION (SUCH AS A CLIP) IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. IT SHOULD BE NOTED THAT IF RESISTANCE IS FELT DURING FIRING, THE FIRING SEQUENCE SHOULD BE STOPPED AND THE CARTRIDGE RELOAD SHOULD BE REPLACED. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR WARNINGS AND PRECAUTION REGARDING FIRING ACROSS HARD OBJECTS. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE RELOADS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. RELOAD B: BATCH: J5HC66. MANUFACTURING DATE: 07/18/2012; PRODUCT EXP. DATE: 06/18/2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, FIRST PRESS NAIL IS NOT COMPLETELY AND CAN'T FIRING. AFTER CHANGE USE TYCO OF PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116287 ENDOPATH** ETS FLEX45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1