BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 22376728 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-05053
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    December 6, 2019
    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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025 D4: BATCH#: UNK B3: UNKNOWN; CAPTURED AS AWARENESS DATE. 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 BATCH HISTORY 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

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: A COMPARATIVE STUDY OF MODIFIED RADICAL MASTECTOMY USING HARMONIC SCALPEL AND ELECTROCAUTERY. AUTHOR: S V S DEO, N K SHUKLA, S ASTHANA, B NIRANJAN, G SRINIVAS CITATION: SINGAPORE MED J 2002 VOL 43(5):226-228. THIS STUDY AIMED TO COMPARE THE OPERATIVE DETAILS AND MORBIDITY OF 23 HARMONIC SCALPEL MODIFIED RADICAL MASTECTOMY (MRMS) WITH 23 MATCHED CONTROLS UNDERGOING MRM WITH ELECTROCAUTERY. BETWEEN DEC 1998 AND AUG 1999, 23 PATIENTS (MEAN AGE OF 51±11 YEARS) WITH BREAST CANCER UNDERWENT MRM USING A HARMONIC SCALPEL (ULTRACISION, ETHICON ENDOSURGERY INC., USA). THESE WERE CASE MATCHED TO 23 PATIENTS (MEAN AGE OF 50±10 YEARS) WITH BREAST CANCER WHO UNDERWENT MRM USING ELECTROCAUTERY DURING THE SAME PERIOD. IN THE HARMONIC SCALPEL GROUP, FLAPS WERE RAISED USING THE COAGULATING SHEARS (CS) ATTACHMENT OF HARMONIC SCALPEL. THE BLUNT EDGE OF THE OPEN CS BLADE WAS USED FOR FLAP DISSECTION AND COAPTIVE COAGULATION MODE WAS USED TO OCCLUDE AND TRANSECT THE BLOOD VESSELS MORE THAN 3 MM DIAMETER. AXILLARY DISSECTION WAS PERFORMED USING THE FLAT SURFACE OF THE CS BLADE. POSTOPERATIVELY, FOUR PATIENTS IN THE HARMONIC SCALPEL GROUP DEVELOPED SEROMAS. NONE OF THE PATIENTS IN BOTH THE GROUPS DEVELOPED WOUND INFECTION, FLAP NECROSIS OR POST OPERATIVE HAEMATOMA. MODIFIED RADICAL MASTECTOMY CAN BE SAFELY PERFORMED WITH A HARMONIC SCALPEL WITH A SIGNIFICANT REDUCTION IN THE BLOOD LOSS AND DURATION OF DRAINAGE IN COMPARISION TO ELECTROCAUTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313680 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) HARMONIC SCALPEL CURVED SHEAR GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention