BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION COAGULATOR 10 FR-6"

    MDR report key: 1870466 · Received October 6, 2010

    Report

    Report Number
    1717344-2010-00679
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 6, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    DWG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE#: (B)(6). DATE OF INITIAL REPORT: (B)(6)2010. THE INCIDENT DEVICE HAS BEEN REC'D AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE SHAFT WAS BENT, THE DEVICE CONTINUED TO ACTIVATE AFTER THE SURGEON HAD TAKEN HIS FINGER OFF THE ACTIVATION BUTTON. NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTION COAGULATOR 10 FR-6" ELECTROSURGICAL ACCESSORY DWG COVIDIEN LP (VALLEYLAB) 188578

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK