BEUDAMED
    FDA Adverse Event Summary report: N

    ETHICON ENDO-SURGERY, LLC

    MDR report key: 2887630 · Received December 19, 2012

    Report

    Report Number
    MW5028326
    Date Received
    December 19, 2012
    Date of Event
    November 9, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ETHICON ENDOSURGERY INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGERY FOR PROLAPSE AND HEMORRHOIDS, THE SURGEON ATTEMPTED TO DO A PPH BUT THE DEVICE MISFIRED. IT LOOKED LIKE IT FIRED A STAPLE LINE AROUND 3/4 OF THE ANAL CANAL, BUT DID NOT EXCISE ANY HEMORRHOIDAL TISSUE. IN DOING THIS IT CREATED A SEPARATION OF THE MUCOSA PROXIMAL TO THE MISFIRED STAPLING DEVICE. IT DID NOT EXCISE THE HEMORRHOIDAL TISSUE, BUT SOME OF THE MUCOSA, MAYBE SOME OF THE SUBMUCOSA PROXIMAL TO WHERE THE STAPLES FIRED. NOTHING WAS STAPLED ANTERIORLY, BUT THERE WAS A DEFECT AS WELL ANTERIORLY, SO IT WAS 360 DEGREES AROUND. REQUIRED REPAIR OF THE 360-DEGREE RECTAL LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, LLC 1 PROXIMATE PPH GAG ETHICON ENDOSURGERY INC. PPH03 J4CD55

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention