BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERCI FASCIAL CLOSURE

    MDR report key: 3951966 · Received June 26, 2014

    Report

    Report Number
    3951966
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    March 28, 2014
    Report Date
    June 26, 2014
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE CLOSURE DEVICE DURING LAPAROSCOPIC SURGERY. THE SHARP END OF THE DEVICE BROKE OFF AND FELL INSIDE THE PATIENT'S ABDOMEN. THE PIECE WAS RETRIEVED LAPAROSCOPICALLY, AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373248 BERCI FASCIAL CLOSURE SUBCUTANEOUS FASCIA CLOSURE KOG KARL STORZ ENDOSCOPY-AMERICA, INC. 26173AM OX 02

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR