BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 22365514 · Received June 30, 2025

    Report

    Report Number
    3005075853-2025-04908
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    November 6, 2019
    Report Date
    June 30, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B3: UNKNOWN; CAPTURED AS AWARENESS DATE. DATE SENT: 6/30/2025. 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 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. 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: IT IS STATED: ¿WOUND INFECTION¿ AND ¿SKIN SWELLING¿ OCCURRED. HOW WAS THE WOUND INFECTION HANDLED? HOW WAS THE SKIN SWELLING HANDLED? DID THE PATIENT NEED TO BE HOSPITALIZED FOR THE WOUND INFECTION OR SKIN SWELLING? DID THE PATIENT NEED TO BE RE OPERATED ON? WHAT IS THE CURRENT CONDITION OF THE PATIENT? 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 : HARMONIC SCALPEL COMPARED WITH BIPOLAR ELECTRO-CAUTERY HEMORRHOIDECTOMY: A RANDOMIZED CONTROLLED TRIAL. AUTHOR : A.A. ABO-HASHEM*, A. SARHAN, A.M. ALY. CITATION: INTERNATIONAL JOURNAL OF SURGERY 8 (2010) 243¿247 / DOI:10.1016/J.IJSU.2010.01.010. THE PURPOSE OF THIS SINGLE-BLIND RANDOMIZED CONTROLLED TRIAL WAS TO PRESENT THE EXPERIENCE IN USING HARMONIC SCALPEL IN HEMORRHOIDECTOMY AND EVALUATING THE POSTOPERATIVE COMPLICATIONS IN COMPARISON TO THE USE OF BIPOLAR ELECTROCAUTERY. FROM JULY 2007 TO DEC 2008, A TOTAL OF 64 PATIENTS UNDERWENT SURGICAL EXCISION OF COMPLEX GRADE III OR GRADE IV HEMORRHOIDS. THE PATIENTS WERE PROSPECTIVELY RANDOMIZED INTO TWO GROUPS: GROUP (A) [N=32 (N=20 MALE, N=12 FEMALE, MEAN AGE 46 ± 3.2 YEARS)] IN WHOM HARMONIC SCALPEL WAS USED AND GROUP (B) [N=32 (N=18 MALE, N=14 FEMALE, MEAN AGE 44 ± 2.1YEARS)] WHERE BIPOLAR ELECTROCAUTERY CLAMP WAS USED. IN GROUP A, A MODIFIED FERGUSON THREE QUADRANT HEMORRHOIDECTOMY WAS PERFORMED IN ALL PATIENTS, USING HARMONIC SCALPEL (ETHICON). SURGICAL INCISIONS WERE LEFT OPEN IN ALL CASES. POSTOPERATIVE COMPLICATIONS INCLUDED WOUND INFECTION (N=1) AND SKIN SWELLING (N=8). THIS STUDY DEMONSTRATES SIGNIFICANTLY REDUCED POSTOPERATIVE PAIN AFTER HARMONIC SCALPEL HEMORRHOIDECTOMY COMPARED WITH BIPOLAR ELECTRO-CAUTERY HEMORRHOIDECTOMY. MOST LIKELY, THIS RESULT CAME FROM THE AVOIDANCE OF EXCESSIVE LATERAL THERMAL INJURY CAUSED BY BIPOLAR ELECTROCAUTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290567 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention