BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ECHELON FLEX STAPLER

    MDR report key: 5917217 · Received August 26, 2016

    Report

    Report Number
    MW5064438
    Event Type
    Injury
    Date Received
    August 26, 2016
    Date of Event
    July 5, 2016
    Report Date
    August 26, 2016
    Manufacturer
    J AND J
    Product Code
    GAG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING A ROBOTIC ASSISTED RADICAL PROSTATECTOMY. DURING USE WITH AN ETHICON ECHELON FLEX 45 STAPLER INTERNALLY IN THE PATIENT THE STAPLER JAMMED AND WOULD NOT RELEASE. SURGEON WAS UNABLE TO REMOVE IT FROM THE PT. SURGEON WAS THEN REQUIRED TO CONVERT TO AN OPEN PROCEDURE. PT DISCHARGED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557845 ETHICON ECHELON FLEX STAPLER ETHICON ECHELON FLEX STAPLER GAG J AND J N5415R

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention