BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** HCS PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH)

    MDR report key: 1992739 · Received February 15, 2011

    Report

    Report Number
    3005075853-2011-00618
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    November 20, 2010
    Report Date
    January 26, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K030925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). BREAKAWAY WASHER CUT OFF CENTER. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH ONLY ONE STAPLE PRESENT; THE BREAKAWAY WASHER WAS PRESENT AND WITH AN OFF-CENTER CUT. IT APPEARS POSSIBLE THAT THE ANVIL WAS PUSHED FAR ENOUGH OFF CENTER TO RESULT IN AN OFF CENTER CUT OF THE BREAKAWAY WASHER. WHILE NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE ANVIL TO BECOME OFF CENTER, IT IS POSSIBLE THAT EXCESSIVE THICK TISSUE UNEVENLY LOADED WAS ON THE DEVICE WHILE ATTEMPTING TO FIRE, RESULTING IN AN INCOMPLETE STAPLE LINE. FOR MORE INFORMATION PLEASE REFERENCE THE INSTRUCTIONS FOR USE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED AND THE DEVICE 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. 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 STARR PROCEDURE, THE SURGEON HAD THE FEELING THAT THE DEVICE HAD NOT CLOSED PROPERLY. IN FACT, WHEN HE CHECKED THE STAPLE LINE, HE SAW THAT THE DEVICE HAD CUT THE ANTERIOR PART OF THE RECTUM BUT HAD FAILED TO APPLY THE TWO ROWS OF STAPLES. THEREFORE, HE HAD TO MANAGE THE BLEEDING AND USE A NEW LIKE DEVICE IN ORDER TO CARRY OUT AND FINISH THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** HCS PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1