BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 22376348 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-05044
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    July 18, 2012
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025. B3: PUBLICATION YEAR OF 2012. 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. UNOBTAINABLE. 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: TOTAL LAPAROSCOPIC SIGMOID AND RECTAL SURGERY IN COMBINATIONWITH TRANSANAL ENDOSCOPIC MICROSURGERY: A PRELIMINARY EVALUATIONIN CHINA.AUTHOR: YI HAN, YONG-GANG HE, HAO-BO ZHANG,KE-ZHI LV, YA-JIE ZHANG, MOU-BIN LIN,LU YIN.CITATION: SURG ENDOSC (2013) 27:518¿524; DOI 10.1007/S00464-012-2471-5.THIS PROSPECTIVE STUDY WAS TO EVALUATE THE FEASIBILITY AND SAFETY OF TOTAL LAPAROSCOPIC SIGMOID AND RECTAL SURGERY WITHOUT ABDOMINAL INCISION IN COMBINATION WITH TRANSANAL ENDOSCOPIC MICROSURGERY (TEM). FROM MAY 2010 TO OCTOBER 2011, 34 PATIENTS (MALE=19, FEMALE=15; MEAN AGE=56.5 YEARS, AGE RANGE=41-78 YEARS; MEAN BMI=24.6, BMI RANGE=19.8-30.3) WITH COLON AND RECTAL TUMORS WERE TREATED BY TOTAL LAPAROSCOPIC SURGERY. DURING THE PROCEDURE, A CIRCUMFERENTIAL INCISION OF THE RECTUM AT LEAST 2 CM BELOW THE TUMOR WAS MADE BY USING A HARMONIC SCALPEL (ETHICON) LAPAROSCOPICALLY. TO DELIVER MOBILIZED RECTUM AND SIGMOID COLON THROUGH RESECTOSCOPE AND FINISH THE ANASTOMOSIS, A CIRCULAR STAPLER (COVIDEN OR ETHICON DST SERIES EEA 33 MM) WAS INSERTED TRANSANALLY, AND AN END-TO-END ANASTOMOSIS WAS LAPAROSCOPICALLY CREATED UNDER DIRECT VISUAL CONTROL. IN CASE THE COLON COULD NOT BE SUFFICIENTLY MOBILIZED TO BE PULLED OUT THROUGH THE ANUS, THE PROXIMAL COLON WAS RESECTED TRANSVERSELY USING A HARMONIC SCALPEL. REPORTED COMPLICATIONS INCLUDED AVERAGE BLOOD LOSS OF 200.2 ML (RANGE 55-450 ML) [HARMONIC SCALPEL (N=?), CIRCULAR STAPLER (N=?)]; AND POST-OPERATIVE ANASTOMOTIC LEAKAGE [CIRCULAR STAPLER (N=?)] IN WHICH FIVE WERE CONSERVATIVELY TREATED WITH PELVIC LAVAGE, FASTING, AND TOTAL PARENTERAL NUTRITION FOR 2¿6 WEEKS, ONLY ONE PATIENT UNDERWENT SECONDARY ILEOSTOMY. IN CONCLUSION, THIS PRELIMINARY STUDY INDICATED THAT TOTAL LAPAROSCOPIC SIGMOID AND RECTAL SURGERY IN COMBINATION WITH TEM WAS A SAFE, FEASIBLE, AND MINIMALLY INVASIVE TECHNIQUE. THIS ADVANCED SURGICAL TECHNIQUE WAS DEVELOPED BY COMBINING LAPAROSCOPY WITH THE CONCEPT OF NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270346 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.