BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5MM X 34CM SCISSOR CRTR 10/BOX

    MDR report key: 3110980 · Received May 8, 2013

    Report

    Report Number
    2027111-2013-00158
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 6, 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 TO 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 LAPAROSCOPY. "I WAS SCRUBBED IN AND HEARD "SIZZLING" THEN SAW SMOKE COMING FROM THE TROCAR SITE. UPON REMOVAL OF THE SCISSOR AND TROCAR, WE COULD SEE AN OBVIOUS BURN AT THE TROCAR SITE IN THE LEFT UPPER QUADRANT." INTERVENTION: SILVODENE CREAM WAS APPLIED TO BURN. PATIENT STATUS: STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200149 5MM X 34CM SCISSOR CRTR 10/BOX NONE LRW APPLIED MEDICAL CB010 1187166

    Patients

    Seq Age Sex Outcome Treatment
    1 Other