BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 2140497 · Received June 27, 2011

    Report

    Report Number
    3005075853-2011-02593
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 31, 2011
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. CUSTOMER WILL NOT RELEASE THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, THE DEVICE WOULD NOT OPEN AFTER FIRING. NO OTHER INFORMATION IS AVAILABLE ABOUT PROBLEM BUT THE CALLER STATED THAT NO PATIENT INJURY WAS REPORTED. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THE DEVICE WILL NOT BE RELEASED AT THIS TIME. ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? UNK. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? UNK. IF ECHELON, DURING WHICH STROKE DID THE EVENT OCCUR? UNK. WHAT COLOR CARTRIDGE WAS BEING USED? UNK. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? UNK. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? UNK. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? UNK. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? UNK. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? UNK. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? UNK. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43J8W

    Patients

    Seq Age Sex Outcome Treatment
    1