BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 2820847 · Received November 6, 2012

    Report

    Report Number
    3005075853-2012-05031
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 29, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL QUESTIONS AND ANSWERS: WAS THE DEVICE COMPLETELY CLOSED AND WITHIN THE FIRING RANGE PRIOR TO FIRING THE DEVICE? YES. WAS THE TISSUE EVENLY DISTRIBUTED IN THE DEVICE PRIOR TO FIRING? YES. WHERE IN THE STAPLE LINE WERE THE MALFORMED STAPLES? UNK. WAS THERE ANY BLEEDING OR LEAKING FROM THE STAPLE LINE? BLEEDING AT 5 O'CLOCK, LEAKING BETWEEN 9 AND 3 O'CLOCK.

    Additional Manufacturer Narrative · 1

    (B)(4). 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, A 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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT IS UNKNOWN HOW MUCH BLOOD THE PATIENT LOST. THERE WERE NO BLOOD TRANSFUSION NEEDED. THE OR TIME WAS EXTENDED DUE TO THE SURGEON HAVING TO SUTURE THE AREAS TO STOP THE BLEEDING. THE PATIENT IS CURRENTLY STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS DIDN`T CLOSE. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CD47

    Patients

    Seq Age Sex Outcome Treatment
    1