BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE CIRCULAR STAPLER

    MDR report key: 5162646 · Received October 20, 2015

    Report

    Report Number
    3005075853-2015-06660
    Event Type
    Injury
    Date Received
    October 20, 2015
    Date of Event
    September 23, 2015
    Report Date
    September 24, 2015
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED AFFILIATE: WHAT IS THE PATIENT'S CURRENT CONDITION? THE PATIENT HAS BEEN DISCHARGED. WHAT WERE THE INDICATIONS FOR SURGERY? THE PATIENT WAS DIAGNOSED AS CARCINOMA OF COLON. HOW WAS THE PURSE STRING CREATED? IT WAS CREATED WITH PURSE STRING FORCEPS AT THE TYING NOTCH. WHICH INCISION WAS BLEEDING (CIRCULAR OR LINEAR)? CIRCULAR. WERE BLOOD PRODUCTS ADMINISTERED? NO. ARE DEVICES BEING RETURNED FROM THE FIRST PROCEDURE? SECOND PROCEDURE? ALL DEVICES HAVE BEEN DISCARDED. NO DEVICE WILL BE RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. BATCH # UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A COLECTOMY PROCEDURE, THE PATIENT WAS IN ICU BEFORE HAVING THE COLECTOMY. DURING THE COLECTOMY PROCEDURE, WHICH BEGAN AT 8 AM ON (B)(6) 2015, THE SURGEON USED THE DEVICE TO ANASTOMOSE INTESTINES END-TO-SIDE AND A LINEAR CUTTER TO CLOSE THE INCISION; WHICH WAS USED TO PUT THE DEVICE INTO THE INTESTINE TUBE. AFTER THE PROCEDURE WAS FINISHED, NO ABNORMALITIES WERE DETECTED AT THAT TIME. BUT AT 1 AM (B)(6) 2015, THE PATIENT WAS FOUND BLEEDING IN THE ICU. EXAMINATION RESULT INDICATED THE PATIENT HAD EXCESS HEME. THE SURGEON HAD TO PERFORM REVISION SURGERY. THE ORIGINAL INCISION WAS OPENED AND HAND SEWING PLUS A NEW LINEAR CUTTER WERE USED TO COMPLETE THE SURGERY. THE PATIENT IS STILL IN ICU FOR FURTHER OBSERVATION. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691928 PROXIMATE CIRCULAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1