BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO ILS 25MM, CURVED

    MDR report key: 1913110 · Received December 2, 2010

    Report

    Report Number
    3005075853-2010-06813
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. SURGEON IS AN EXTREMELY EXPERIENCED EES STAPLER USER (+1000 CASES WITH OUR CIRCULAR, ENDOCUTTERS), BUT HE HAS A NEW PARTNER WHO HAS VERY LIMITED EXPERIENCE WITH OUR PRODUCTS. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OP OF A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, POST OP (B)(6), THE PATIENT HAD A GASTRO-JEJUNOSTOMY LEAK. THE PATIENT WAS ADMITTED ON (B)(6) 2010. DURING THE ORIGINAL DATE OF SURGERY, THE CIRCULAR AND ENDOCUTTER DEVICES WERE USED AND THE SURGEON DID NOT NOTICE ANYTHING WITH THE DEVICES' FUNCTION AT THAT TIME. A LEAK TEST WAS PERFORMED AND THERE WERE NO LEAKS PRESENT. THE AGE AND GENDER OF THE PATIENT ARE UNKNOWN. THE DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO ILS 25MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R