BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45 LONG

    MDR report key: 1913623 · Received December 3, 2010

    Report

    Report Number
    3005075853-2010-06825
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.THE ACCOUNT WILL NOT RELEASE THE DEVICES, IF THE DEVICES ARE RELEASED A SUPPLEMENTAL REPORT WILL BE SENT.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 LAPAROSCOPIC GASTRIC BYPASS PROCEDURE THE SURGEON USED THE FIRST DEVICE AND HAD A DIFFICULT TIME CLOSE IT, HE PLACED IT DOWN THE TROCAR AND THEN COULD NOT OPEN IT TO PLACE ON THE JEJUNUM; THE SURGEON REMOVED THE DEVICE AND DID NOT USE IT. THEY THEN USED A SECOND LIKE DEVICE, IT CLOSED BUT WHEN HE TRIED TO REPOSITION IT THE DEVICE WOULD NOT OPEN, THE SECOND DEVICE WOULD NOT OPEN AND WAS REMOVED BY FIRING ANOTHER DEVICE ON EITHER SIDE OF THE JAW. THE SURGEON THE USED THE OTHER DEVICE WITH A WHITE RELOAD TO CONTINUE AND COMPLETE THE PROCEDURE. THE SURGEON STATED HE HEARD A POPPING SOUND WITH THE FIRST DEVICE BUT NOT THE SECOND WHEN CLOSING THE DEVICES. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4TG2R

    Patients

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