BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 1911793 · Received December 1, 2010

    Report

    Report Number
    3005075853-2010-06770
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 10, 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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ON (B)(6) 2010, EES (B)(4) SPOKE WITH (B)(6) AND HE INDICATED EVERYTHING WAS PERFECT WITH THE USE OF THE DEVICE. HE CONSIDERED DIVERTING BUT BECAUSE THE DEVICE WORKED SO WELL AND THE ANASTOMOSIS LOOKED SO GOOD HE DECIDED NOT TO. THE PATIENT WAS A CHRONIC SMOKER UNDERGOING CHEMOTHERAPY, WAS (B)(6) POST RADIATION TREATMENT AND HAD A BOWEL MOVEMENT ON POST OP (B)(6). (B)(6), IN EXAMINING THE SPECIMEN STAPLE LINE, THOUGHT THAT SEEING BOWED "B" FORM PERHAPS INDICATED STAPLE MALFUNCTION OR MISALIGNMENT. HE FELT THIS, COMBINED WITH THE OTHER CLINICAL ISSUES, CONTRIBUTED TO THE STAPLE LINE FAILURE. I EXPLAINED TO HIM THAT ROTATION OF INDIVIDUAL STAPLES WAS NOT UNCOMMON AND IN NO WAY AFFECTED THE INTEGRITY OF THE STAPLE LINE. 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 (B)(6) POST-OP OF A COLON PROCEDURE, THE SURGEON NEEDED TO PERFORM A REOPERATION BECAUSE THE PATIENT PRESENTED WITH AN INTRA-ABDOMINAL LEAK AND SEPSIS. IT WAS FOUND THAT THE INSPECTED STAPLE LINE CONTAINED MALFORMED STAPLES AT THE ANASTOMOTIC SITE. MALFORMED STAPLES WERE NOT ORIGINALLY NOTICED DURING THE PROCEDURE SINCE THE TISSUE PASSED A LEAK TEST AND THE DONUTS WERE COMPLETE. THE SURGEON ALSO STATED THAT THE DEVICE ACTED COMPLETELY NORMAL WHEN FIRED. THE PATIENT ALSO HAD RADIATED TISSUE. THE DOCTOR RESECTED THE ANASTOMOSIS AND GAVE THE PATIENT A COLOSTOMY. PATIENT ALSO IS ON ANTIBIOTICS. THE DEVICE WAS DISCARDED.

    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