BEUDAMED
    FDA Adverse Event Summary report: N

    5MM X 34CM SCISSOR CRTR 10/BOX

    MDR report key: 2940935 · Received January 30, 2013

    Report

    Report Number
    2027111-2013-00017
    Date Received
    January 30, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 30, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    LRW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE WITH 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    OPERATIVE DIAGNOSTIC LAPAROSCOPY - "REMOVED SCISSOR FROM TROCAR AND SCISSOR WAS PLACED ON PT. SCISSOR BEGAN TO SPARK AND SMOKE WHILE ON PT LEAVING A BURN MARK ON PT LOWER RIGHT QUADRANT." PT STATUS: "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40742 5MM X 34CM SCISSOR CRTR 10/BOX NONE LRW APPLIED MEDICAL CB010 1162115

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R| S 5MM TROCARS| 5MM SCOPE