BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 22375018 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-05001
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    December 9, 2014
    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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025. B3: PUBLICATION YEAR OF 2014. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE, NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT: PLEASE PROVIDE THE SPECIFIC NUMBER OF PATIENTS WHO HAD EVENT OF BILE LEAKAGE AND WOUND INFECTION USING THE ENDOSCOPIC LINEAR STAPLER (ETHICON) DEVICE. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. 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: ONCOLOGICAL AND SURGICAL RESULTS OF LAPAROSCOPIC VERSUS OPEN LIVER RESECTION FOR HCC LESS THAN 5 CM: CASE-MATCHED ANALYSIS. AUTHOR(S): SAM-YOUL YOON, KI-HUN KIM, DONG-HWAN JUNG, AMI YU, SUNG-GYU LEE. CITATION: SURG ENDOSC (2015) 29:2628¿2634; DOI 10.1007/S00464-014-3980-1. THE AIMED OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE SURGICAL AND ONCOLOGICAL RESULTS OF LAPAROSCOPIC LIVER RESECTION (LLR) FOR HEPATOCELLULAR CARCINOMA (HCC) BY COMPARING LAPAROSCOPIC AND OPEN LIVER RESECTION (OLR). BETWEEN JULY 2007 AND AUGUST 2011, 1050 PATIENTS RECEIVED LIVER RESECTION FOR HCC. A TOTAL OF 174 PATIENTS (FEMALE=44, MALE=130; MEAN AGE 55.0 YEARS, AGE RANGE=49 ¿ 61 YEARS) WERE UNDER OLR GROUP AND 58 PATIENTS (FEMALE=13, MALE=45; MEAN AGE=54.3 YEARS, AGE RANGE=49 ¿ 63 YEARS) WERE UNDER LLR GROUP. DURING LAPAROSCOPIC LIVER RESECTION, TRANSECTION OF LIVER PARENCHYMA WAS PERFORMED USING HARMONIC SCALPEL (ETHICON). SMALL BRANCHES OF GLISSON¿S PEDICLES WERE CLIPPED BY METAL CLIP, AND LARGE GLISSON¿S PEDICLES WERE LIGATED USING A KNOT PUSHER OR ENDOSCOPIC LINEAR STAPLER (ETHICON) WITH 45 MM GOLD CARTRIDGE. AFTER PARENCHYMAL DISSECTION, ENDOSCOPIC LINEAR STAPLER (ETHICON) WITH 45 MM WHITE CARTRIDGE WAS USED TO LIGATE THE MAIN HEPATIC VEINS. REPORTED COMPLICATIONS IN LLR GROUP INCLUDED BILE LEAKAGE [HARMONIC SCALPEL (N=2); ENDOSCOPIC LINEAR STAPLER (N=?)] REQUIRING INTERVENTIONAL DRAINAGE OR STENT PLACEMENT; WOUND INFECTION [ENDOSCOPIC LINEAR STAPLER (N=3)]. IN CONCLUSION, LLR IS A SAFE AND FEASIBLE ALTERNATIVE FOR SELECTED PATIENTS WITH HCC (<5 CM) AND WAS SHOWN NOT TO INCREASE THE TUMOR RECURRENCE RISK OR ADVERSELY AFFECT ONCOLOGIC OUTCOMES. LLR IS A SAFE AND DEVELOPING TECHNIQUE IN A SELECT GROUP OF PATIENTS WITH HCC. LLR HAS THE ADVANTAGES OF RAPID RECOVERY AND LOW MORBIDITY WITH ACCEPTABLE ONCOLOGICAL AND PATHOLOGICAL PARAMETERS. IT MAY BE AN OPTIMAL AND PROMISING METHOD OF HEPATECTOMY IN HCC (<5 CM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314449 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