BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 2162894 · Received July 15, 2011

    Report

    Report Number
    3005075853-2011-02849
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 23, 2011
    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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: DO YOU KNOW HOW MUCH BLOOD LOSS AND WAS THE PATIENT GIVEN A BLOOD TRANSFUSION? PATIENT LOST ABOUT HALF UNIT. NO, PATIENT DIDN'T RECEIVE BLOOD TRANSFUSION.

    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 DEVICE PRODUCED THE CRUNCH SOUND AS IT CUT THE BREAKAWAY WASHER AS INTENDED. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE REPORTED EVENT, IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE AND WASHER PRESENCE BY AN (B)(4), 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 MINIMALLY INVASIVE PROCEDURE FOR HEMORRHOID, BY THE DOCTOR, THE DEVICE MISFIRED. WHEN THE DEVICE WAS FIRED, NO CRUNCH SOUND WAS HEARD AND IT CUT THE TISSUE BUT NO STAPLES WERE SEEN AT ALL EITHER ON MUCOSA OR LYING FREE; PATIENT BLED BADLY AND THEN THE SURGEON TOOK ALL SUTURES MANUALLY CIRCUMFERENTIALLY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA H4324X

    Patients

    Seq Age Sex Outcome Treatment
    1