BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 2862388 · Received December 10, 2012

    Report

    Report Number
    3005075853-2012-05514
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 15, 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. TWO DEVICES WERE RETURNED FOR ANALYSIS: DEVICE (A) 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. DEVICE (B) 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTENDED PROLAPSECTOMY ACCORDING TO THE LONG PROCEDURE, THE FIRST DEVICE USED CREATED ONLY A POSTERIOR HALF STAPLE LINE. THEREFORE, A SECOND DEVICE WAS USED TO RESECT THE MISSING ANTERIOR PART. AFTER EXTRACTING THE SECOND DEVICE, THE SURGEON NOTICED AN ALMOST COMPLETE DIASTASES OF THE ANASTOMOSIS. THE SURGEON HAD TO APPLY INTERRUPTED SUTURES ON THE ANASTOMOTIC STAPLE LINE. 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. UNK J4CG9J

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR