BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2051557 · Received April 12, 2011

    Report

    Report Number
    3005075853-2011-01468
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 23, 2011
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. REQUESTED ADDITIONAL INFORMATION. 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 AN UNKNOWN PROCEDURE, THE TARGET RECTUM WAS RESECTED WITH THE SC60A LOADED WITH ECR60D. THE SC60A WAS FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE FORMED PROPERLY. NEXT, THE CDH29 WAS USED TO ANASTOMOSE BY DOUBLE STAPLING TECHNIQUE. THE STAPLES WERE FORMED PROPERLY AND THE DOUGHNUTS WERE PROPER. AFTER ANASTOMOSIS, THE LEAK TEST WAS PERFORMED AND THEN THE OPERATION WAS FINISHED. THE DOCTOR COMMENTED AS FOLLOWS; THE TARGET TISSUE WAS THIN AND IT WAS CLAMPED EVENLY. THE LOCATION OF THE INDICATOR OF THE CDH29 WAS WITHIN THE GAP SETTING SCALE. THE CDH29 DID NOT FIRE ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP. "THE WASHER'S CRUNCH AND THE FEEL WHEN THE TRIGGER GRASPED COMPLETELY." AFTER SURGERY, A MINOR LEAK OCCURRED FROM THE DOUBLE STAPLE LINE. AS OF NOW THERE IS NO DETAILED INFORMATION REGARDING THE ACCRUAL DATE OF LEAK. ON (B)(6) 2011, THE DRAINAGE WAS PERFORMED. ALL DEVICES WERE 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