BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 1914907 · Received December 6, 2010

    Report

    Report Number
    3005075853-2010-06871
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 22, 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 (B)(6) 2010: THE TISSUE WAS NOT SO THICK AND THE TISSUE WAS DISTRIBUTED EVENLY. THE DEVICE WAS NOT FIRED ACROSS OR NEAR THE HARD OBJECTS EXCEPT ECHELON60 STAPLE LINE. THERE WERE NOT DIFFICULTIES IN ATTACHING THE ANVIL TO DEVICE. THE INDICATOR WAS WITHIN THE GREEN RANGE. THE DOCTOR CONFIRMED THE WASHER'S CRUNCH AND THE FEEL WHEN THE DEVICE WAS FIRED. THERE WERE NOT DIFFICULTIES IN FIRING AND REMOVING THE DEVICE. THE WASHER WAS CUT COMPLETELY. ALTHOUGH THE COLONOFIBEROSCOPY WAS PERFORMED, THE STAPLE'S FORMATION WAS NOT CONFIRMED. THE DOCTOR COMMENTED THAT THE CAUSES MAY CONTRIBUTE TO STAPLE'S FORMATION OR THE PATIENT'S CONDITION. PATIENT STATUS: THE PATIENT HAD ALREADY LEFT THE HOSPITAL. 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 LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, THE TARGET TISSUE WAS RESECTED WITH EC60 LOADED WITH A GOLD CARTRIDGE AND THEN THE DEVICE WAS USED FOR ANASTOMOSIS BY DOUBLE STAPLING TECHNIQUE. REINFORCEMENT MATERIAL WAS NOT USED. THERE WAS NO PROBLEM AT THE LEAK TEST AND COLONOFIBROSCOPY RIGHT AFTER THE ANASTOMOSIS. A FEW HOURS LATER, MUCOUS AND BLOODY STOOL WAS FOUND, BUT IT WAS SUBSIDED SHORTLY. ON THE NEXT DAY OF THE OPERATION, THE DRAINAGE OF FLUID GOT TURBID, SO THE DOCTOR SUSPECTED THAT A MINOR LEAK OCCURRED. THE SYMPTOM WAS SUBSIDED BY PERFORMING DRAINAGE, ADMINISTERING ANTIBIOTIC AND THE PATIENT HAD TO STOP EATING. THE PATIENT'S HOSPITALIZATION WAS EXTENDED BY ABOUT A WEEK. THE PATIENT IS STILL IN THE HOSPITAL AS OF (B)(6). 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 74 YR Hospitalization| O| R