BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2170513 · Received July 21, 2011

    Report

    Report Number
    3005075853-2011-02926
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE NOT RETURNED. THREE ATTEMPTS WERE MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? DURING WHICH STROKE DID THE EVENT OCCUR? WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? HOW DID THEY MANAGE TO OPEN THE DEVICE? WAS THERE ANY TISSUE DAMAGE? HAD ADDITIONAL TISSUE BE REMOVED? PLEASE SPECIFY IN CM. IF SO, HOW WAS IT REPAIRED? WHAT IS THE AGE AND SEX OF THE PATIENT? WHAT IS THE CURRENT STATUS OF THE PATIENT? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE BATCHES INCLUDED IN THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE DEVICE WAS LOADED WITH AN BLUE RELOAD AND IT WAS POSITIONED FOR SECTIONING AND APPLYING STAPLES ON DUODENUM. AFTER FIRST FIRING, THE TRIGGER WAS NOT ABLE TO ACTION THE BLADE AND AS A CONSEQUENCE THE DEVICE REMAINED BLOCKED ON DUODENUM. IT WAS NECESSARY TO USE ANOTHER DEVICE IN ORDER TO REMOVE THE FIRST DEVICE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. AT THE MOMENT THE DEVICE IS BEING RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H4380M

    Patients

    Seq Age Sex Outcome Treatment
    1