BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS2 SHARP HOOK BLADE SYSTEM

    MDR report key: 9406130 · Received December 3, 2019

    Report

    Report Number
    3005075853-2019-23927
    Event Type
    Injury
    Date Received
    December 3, 2019
    Date of Event
    January 1, 1999
    Report Date
    November 4, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K993054
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DATE OF EVENT: PUBLICATION YEAR OF 1999. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    TITLE: CONIZATION OF THE CERVIX USING HARMONIC SCALPEL. AUTHOR: RYO KONNO, JUN-ICHI AKAHIRA, TSUKASA IGARASHI, HIROMITSU YAMAKAWA, SHINJI SATO AND AKIRA YAJIMA. CITATION: TOHOKU J. EXP. MED., 1999, 189, 171 ¿ 178. THE PURPOSE OF THIS STUDY WAS TO DESCRIBE THE DEVELOPMENT OF A SURGICAL PROCEDURE OF CONIZATION USING HARMONIC SCALPEL (ETHICON) WITHOUT ELECTRIC OR LASER ENERGY. BETWEEN NOV 1997 AND OCT 1998, A TOTAL OF 11 WOMEN [MEAN AGE 34.5 YEARS OLD (RANGE 19-50 YEARS)] WITH CERVICAL INTRAEPITHELIAL NEOPLASIA (CIN) UNDERWENT CONIZATION. THE CONIZATION WAS PERFORMED USING HARMONIC SCALPEL. TO REDUCE BLEEDING, THE BILATERAL DESCENDING BRANCHES OF THE UTERINE ARTERIES WERE LIGATED WITH VICRYL 1-0 (ETHICON) AT 3 AND 9 O¿CLOCK POSITONS. THE ANTERIOR AND POSTERIOR LIPS WERE TIED WITH VICRYL 1-0 AT THE EXTERNAL AREAS OF THE LESION AS RECOGNIZED BY SCHILLER¿S TEST. THE TIED VICRYL WAS USED FOR TRACTION TO SET A GOOD POSITION FOR THE EXCISION OF THE CONE. THE CONICAL PORTION OF THE CERVICAL TISSUE WAS RESECTED BY MEANS OF THE HS2 HOOK BLADE OF THE HS ON LEVEL 3 POWER SETTING. COMPLICATION INCLUDED A (B)(6) WOMAN (G4, P2) WHO HAD POSTOPERATIVE HEMORRHAGE WHICH WAS TREATED WITH BIPOLAR ELECTROCOAGULATION IN THE OUTPATIENT CLINIC. THE SURGICAL METHOD USING HARMONIC SCALPEL IS CHARACTERIZED BY NEGLIGIBLE BLEEDING, A GOOD VISUAL FIELD NOT OBSCURED BY SMOKE AND RESECTION OF AN IDEAL SHAPE THAT FITS THE SIZE OF THE LESION. NO COMPLICATIONS DURING CONIZATION WERE OBSERVED. IT IS CONCLUDED THAT THIS METHOD OVERCOMES MOST PROBLEMS ASSOCIATED WITH CONIZATION USING CONVENTIONAL METHODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194220 HS2 SHARP HOOK BLADE SYSTEM INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1