BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROX*ACCESS 55MM ART STAP THIC

    MDR report key: 1933929 · Received December 21, 2010

    Report

    Report Number
    3005075853-2010-07301
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 12, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT ONE DEVICE ARRIVED IN GOOD VISUAL CONDITIONS AND VOID OF STAPLES. THE DEVICE WAS MANUALLY LOADED WITH STAPLES AND IT WAS TESTED FOR FUNCTIONALITY. THE DEVICE WAS FIRED AND IT FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE; THE STAPLE LINE WAS NOTED TO BE COMPLETE. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLON PROCEDURE, THE CARTRIDGE WAS EMPTY. DURING THE STAPLING, THE SURGEON REPORTED THAT THERE WERE NOT STAPLES IN THE CARTRIDGE. HE VERIFIED AND REPORTED THAT NO STAPLES WERE FOUND INTO THE PATIENT OR OUT THE PATIENT. THE COLON STUMP UNSTAPLED FELL OPEN IN THE ABDOMINAL CAVITY. THE SURGEON RETRIEVED IT MANUALLY AND CLOSED IT BY MANUAL SUTURING. IN THE WEEK FOLLOWING THIS PROCEDURE, THE CONSTANTS OF THE PATIENT IS NOT GOOD (ESPECIALLY FEVER) AND THE PATIENT WAS RE-OPERATED: A FISTULA WAS DISCOVERED ON THE MANUAL SUTURE LINE. TO DATE ((B)(6) 2010) THE PATIENT IS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROX*ACCESS 55MM ART STAP THIC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. F4PU5U

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R