BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 22375951 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-05036
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    December 25, 2009
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025. B3: PUBLICATION YEAR OF 2009. D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: ENDOSCOPIC MINIMALLY INVASIVE THYROIDECTOMY: FIRST CLINICAL EXPERIENCE AUTHOR : THOMAS WILHELM ¿ ANDREAS METZIG CITATION: SURG ENDOSC (2010); 24:1757¿1758. DOI: 10.1007/S00464-009-0820-9 THE AUTHORS DEVELOPED AN EXCLUSIVELY ENDOSCOPIC APPROACH FOR THYROID RESECTION WITH STANDARD INSTRUMENTS USED FOR MINIMALLY INVASIVE SURGERY (DIAMETER, 3.5 MM). THIS ENDOSCOPIC MINIMALLY INVASIVE THYROIDECTOMY (EMIT) TECHNIQUE WAS EVALUATED CAREFULLY BY ANATOMIC AND CADAVER DISSECTIONS AS WELL AS ULTRASOUND STUDIES FOR TECHNICAL REALIZATION AND NEEDS FOR INSTRUMENT DESIGN. ON (B)(6) 2009, A 53-YEAR-OLD MALE PATIENT WITH DYSPHAGIA FOR MORE THAN A YEAR UNDERWENT ENDOSCOPIC MINIMALLY INVASIVE THYROIDECTOMY (EMIT). DURING THE PROCEDURE, THE ISTHMUS WAS DIVIDED ON LEFT SIDE WITH HARMONIC SCALPEL (ETHICON). THE VESSEL OF THE UPPER POLE WERE DIVIDED BY ULTRACISION (ETHICON). THE PATIENT DEVELOPED A MINIMAL SWELLING OF THE NECK AND A SMALL HEMATOMA, WHICH RESOLVED WITHIN 2 WEEKS. THE CLEAR ADVANTAGES OF THIS TECHNIQUE ARE ITS MINIMALLY INVASIVE CHARACTER, ITS REDUCTION OF SURGICAL TRAUMA, ITS DIRECT ACCESS TO SURGICAL PLANES AND SPACES, ITS AVOIDANCE OF SWALLOWING DISORDERS AND POSTOPERATIVE DYSPHAGIA, AND FINALLY, ITS AVOIDANCE OF ANY SKIN SCARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381266 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GENERATOR AND HANDPIECE