BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAP

    MDR report key: 3621458 · Received January 31, 2014

    Report

    Report Number
    1225798-2014-00001
    Event Type
    Injury
    Date Received
    January 31, 2014
    Date of Event
    December 3, 2013
    Report Date
    January 30, 2014
    Manufacturer
    ATC TECHNOLOGIES, INC.
    Product Code
    GEI
    PMA / PMN Number
    K994319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN-PROCESS.

    Description of Event or Problem · 1

    AN ATC TECHNOLOGIES INC. MODULAP, DISPOSABLE UNIPOLAR ELECTROSURGICAL PROBE, BROKE DURING A LAPAROSCOPIC SURGERY (REMOVAL OF THE UTERUS) AND THIS LEAD TO A PERFORATION OF THE PATIENTS BOWEL. SURGERY WAS REQUIRED TO REPAIR THE BOWEL. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68543 MODULAP DISP. UNIPOLAR ELECTROSURGICAL PROBE GEI ATC TECHNOLOGIES, INC. 4155 011302

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention