BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL 5MM DISSECTING HOOK

    MDR report key: 88846 · Received May 5, 1997

    Report

    Report Number
    88846
    Event Type
    Injury
    Date Received
    May 5, 1997
    Date of Event
    March 18, 1997
    Report Date
    April 21, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KNS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A DIAGNOSTIC LAPAROSCOPY, THE REP REPORTED THE SURGEON WAS USING A DH085 THAT MELTED THE 5MM TROCAR AND THE PT'S SKIN WAS BURNED. THE HOSP IS RETURNING THE GENERATOR, FOOT SWITCH, AND THE HAND PIECE FOR EVALUATION. 3/31/97 REC'D MEDWATCH #050121-1997-0002 FROM HOSP STATING "AT THE END OF SURGICAL PROCEDURE-CAUTERY OF ENDOMETRIAL ABLATION-THE 5MM PORT SITE(SUPRA PUBIC)NOTED TO HAVE BURNED AREA ON SKIN. 5MM TROCAR HAD A HOLE AT THE UPPER END OF THE BARREL. THE FIRST INSTRUMENT USED, WAS GETTING HOT. THE STAFF CHANGED TO A BARD ELECTROSURGICAL UNIT(ESU). THE ESU OUTPUT TEST WAS GOOD AND WITHIN SPECIFICATIONS. A 4MM EXCISION OF BURNED SUBCUTANEOUS TISSUE WAS TAKEN, 4 SUTURES OF 3-0 PLAIN SUTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL 5MM DISSECTING HOOK HOOK KNS ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention