BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL DISSECTING HOOK, 10CM

    MDR report key: 212548 · Received February 26, 1999

    Report

    Report Number
    1527736-1999-01109
    Event Type
    Injury
    Date Received
    February 26, 1999
    Date of Event
    February 11, 1999
    Report Date
    February 12, 1999
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THE DEVICE WAS USED DURING A TONSILLECTOMY. IT WAS REPORTED AFTER THE TONSILLECTOMY WAS PERFORMED WITH THE 10CM HARMONIC SCALPEL AND BIPOLAR ELECTROSURGERY, THE PT WAS OBSERVED AS HAVING A BURN ON THE LIP. ELECTROSURGERY AND THE HARMONIC SCALPEL WERE BOTH USED DURING THE CASE. 02/12/1999 REP REPORTS THE PT WAS A 3 YR OLD BOY. THE LEFT CORNER OF THE MOUTH HAD APPROXIMATELY A PEA SIZE BURN. PT WAS TREATED WITH ANTIBIOTICS AND OINTMENT. MD REPORTS 1 DAY POST-OPERATIVE SIGNIFICANT ESCHAR NOTED AND ADVISED THE REP LITIGATION MAY OCCUR. THE HOSP WILL NOT RELEASE THE DEVICE AT THIS TIME. 02/25/1999 MD CONTACTED THIS WRITER. HE STATED THAT WHEN HE WAS USING THE INSTRUMENT HE HEARD A HIGH FREQUENCY SOUND AT ABOUT @ 4,000 - 8,000 HTZ. HE ALSO STATED THAT THE SOUND WOULD COME INTERMITTENTLY THEN STOP. THE BURN ON THE PT WAS NOT OBSERVED UNTIL THE PROCEDURE WAS OVER. MD STATED THAT THE PT IS NOW RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL DISSECTING HOOK, 10CM ULTRASONIC-SURGERY DEVICES - CONVEN LFL ETHICON ENDO-SURGERY - ALB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other| R