BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 1930764 · Received December 16, 2010

    Report

    Report Number
    3005075853-2010-07221
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 28, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 12/3/2010: THE TISSUE WAS NOT SO THICK. THE DEVICE WAS NOT FIRED ACROSS OR NEAR THE HARD OBJECTS. THE INDICATOR WAS WITHIN THE GREEN RANGE. THE DEVICE CONFIRMED THE WASHER¿S CRUNCH AND THE FEEL WHEN THE TRIGGER GRASPED COMPLETELY. WHEN COLONOSCOPY WAS PERFORMED, THE FOUND STAPLES WERE FORMED PROPERLY. THERE WERE NOT DIFFICULTIES IN FIRING AND REMOVING THE DEVICE. AS AMOUNT OF BLEEDING WAS 15CC, NO TRANSFUSION WAS REQUIRED. THE PATIENT WAS GETTING WELL. 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 DURING A HIGH ANTERIOR RESECTION PROCEDURE, THE DEVICE WAS USED FOR ANASTOMOSIS BETWEEN THE COLON AND THE RECTUM. REINFORCEMENT MATERIAL WAS NOT USED. THE DOUGHNUTS WERE FORMED PROPERLY AND THERE WERE NO PROBLEMS AT THE LEAK TEST. HOWEVER, BLEEDING OCCURRED FROM THE ANASTOMOSIS SITE JUST AFTER THE PATIENT LEFT THE OPERATION ROOM. THEREFORE, THE BLEEDING WAS STOPPED WITH CLIPS ENDOSCOPICALLY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE CUSTOMER DISPOSED OF THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R