BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON RELOAD

    MDR report key: 2021527 · Received March 17, 2011

    Report

    Report Number
    3005075853-2011-01048
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 22, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, A SINGLE STAPLE OF RELOAD WAS NOT DISCHARGED CORRECTLY DURING THE FIRING SEQUENCE AND REMAINED LOGGED IN RELOAD AND CAUGHT TISSUE. THE TISSUE WAS CUT BUT VERY SMALL (2MM). ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. SURGERY WAS PROLONGED ONE MINUTE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4UF6G

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR