BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 306999 · Received November 29, 2000

    Report

    Report Number
    1527736-2000-06077
    Event Type
    Injury
    Date Received
    November 29, 2000
    Date of Event
    November 2, 2000
    Report Date
    November 2, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) LCSC5 WAS USED DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE. IT WAS REPORTED BY THE REP THAT THE LCSC5 WAS RESTING EITHER ON THE PT OR ON THE MAYO STAND. THE TIP WAS RESTING ON THE PT'S LEG. THE SURGEON STEPPED ON THE HARMONIC FOOT PEDAL AND ACTIVATED THE BLADE. THE PT WAS BURNED ON THE LEG. ANTIBIOTIC OINTMENT WAS PUT ON THE BURN. IT IS UNKNOWN HOW THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE ULTRASONIC-SURGERY DEVICES - ENDOSC LFL ETHICON ENDO-SURGERY - ALB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention