BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 1111066 · Received August 13, 2008

    Report

    Report Number
    3005075853-2008-01145
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 8/13/2008. EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A HEMORRHOIDECTOMY. THE SURGEON FIRED THE DEVICE AND EVERYTHING SOUNDED AND FIRED PROPERLY. WHEN DEVICE REMOVED FROM THE PT, A DIGITAL EXAM WAS PERFORMED AND FOUND AN ANTERIOR TEAR IN THE COLON WALL NEAR STAPLE LINE. THE COLON WAS EXPOSED INTO THE RECTUM AND PT OPENED TO REPAIR THE COLON TEAR. THERE WERE NO OTHER PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE PPH PROCEDURE SET GDW ETHICON ENDO-SURGERY, LLC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention