BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 1881669 · Received October 25, 2010

    Report

    Report Number
    1527736-2010-00081
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    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

    ADDED ADDITIONAL INFORMATION: AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS

    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 LAP SLEEVE GASTRECTOMY PROCEDURE, THREE FIRINGS WITH THE GREEN RELOAD AND IT RESULTED IN SEROSAL TEARING AND UNFORMED STAPLES I.E.: NO B SHAPED STAPLES AT THE DISTAL END OF THE CARTRIDGE. THIS RESULTED IN OOZING FROM THE UNFORMED STAPLE LINE. OVER SEWING WAS USED TO COMPLETE THE PROCEDURE. SURGERY WAS PROLONGED TWENTY MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD- (B)(4)