BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 3132044 · Received May 29, 2013

    Report

    Report Number
    3005075853-2013-02587
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE SURGEON SAID HIS FIRST FIRING WAS WITH A BLACK RELOAD AND IT JAMMED HALFWAY THROUGH THE CARTRIDGE. HE THEN REVERSED THE KNIFE BLADE AND OPENED UP THE JAWS TO FIND ONLY HALF THE STAPLES IN THE CARTRIDGE HAD BEEN DEPLOYED. HE THEN COMPLETED THE CASE BY OPENING ANOTHER RELOAD AND IT WORKED OK. HE BELIEVES THAT THE RELOAD ONLY HAD HALF THE STAPLES IN IT. WAS THE STAPLE LINE AND CUT LINE EQUAL? THE DEVICE DIDN¿T LAY MANY STAPLES ON THE PATIENT SIDE, AND SOME OF THEM WERE COMPLETELY UNFORMED. HENCE THERE WAS NO EFFECTIVE STAPLE LINE TO MATCH THE CUT LINE. DURING WHICH STROKE DID THE EVENT OCCUR? DURING THE FIRST. THE DEVICE WAS JAMMING AND SURGEON DIDN¿T PROGRESS PAST THE FIRST STROKE. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? AS ABOVE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? THIS WAS THE FIRST FIRING AND IT WAS BLACK. SUBSEQUENT CARTRIDGES USED WERE GREEN. IF BUTTRESSING MATERIAL WAS UTILIZED, WHICH PRODUCT WAS USED? GORE SEAMGUARD WAS USED. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. IF ANY UNEXPECTED NOISES WERE HEARD, WHEN WERE THEY HEARD? UNSURE. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? FIRING WAS MORE DIFFICULT THAN EXPECTED AND DEVICE WAS ¿JAMMING¿. SURGEON REVERSED KNIFE BLADE AFTER FIRST FIRING AND OPENED DEVICE. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NO, PLEASE SEE ABOVE. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? SOME DIFFICULTY DUE TO JAMMING. A PHOTOGRAPH OF THE RELOAD WAS RECEIVED; HOWEVER, IT COULD NOT BE DETERMINED WHAT CAUSED THE COMPLICATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT ONE ECR60T RELOAD WAS RECEIVED PARTIALLY FIRED 1/2. THE CARTRIDGE RELOAD PARTIALLY FIRED IS CONSISTENT WITH AN INCOMPLETE OR INTERRUPTED CYCLE. THE RETURNED RELOAD WAS RESET AND LOADED INTO A TEST DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION AND ACHIEVED ITS COMPLETE STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE THE NURSE REPORTED THAT THE RELOAD DID NOT FIRE ALL THE WAY. THEY RELEASED IT BECAUSE IT ONLY FIRED HALF THE STAPLES. IT DID NOT DAMAGE THE TISSUE. NO PATIENT CONSEQUENCES REPORTED. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237047 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60T, ECR60G