BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EEA

    MDR report key: 9987680 · Received April 22, 2020

    Report

    Report Number
    2647580-2020-01417
    Event Type
    Malfunction
    Date Received
    April 22, 2020
    Date of Event
    August 28, 2019
    Report Date
    May 19, 2020
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523005585
    PMA / PMN Number
    K062850
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    NEW INFORMATION HAS BEEN RECEIVED WITH THE FOLLOWING INFORMATION: REPORTED DEVICE IS NOT AN MDT/COVIDIEN DEVICE (MYOSURE XL BY HOLOGIC). INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ROUX-EX-Y PROCEDURE, THE BLADE OF THE DEVICE WAS DULL AND NOT WORKING. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451443 EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO EEAXL2135 18K30RA 10884523005585

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR