BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELEFLEX

    MDR report key: 7305675 · Received February 28, 2018

    Report

    Report Number
    MW5075601
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    February 1, 2018
    Report Date
    February 27, 2018
    Manufacturer
    TELEFLEX
    Product Code
    PKE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY ONE BLADE OF A TELEFLEX LAPAROSCOPIC FAN RETRACTOR CATALOG #728148 BROKE OFF OF THE RETRACTOR AND FELL INTO THE PATIENT'S ABDOMINAL CAVITY. THE PIECE WAS IMMEDIATELY RETRIEVED BY THE SURGEON AND ALL PIECES WERE ACCOUNTED FOR. THE RETRACTOR AND BROKEN BLADE WERE RETAINED FOR INSPECTION IF NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148614 TELEFLEX LAPAROSCOPIC LIVER RETRACTOR PKE TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention