BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 22374870 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-04997
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    May 25, 2018
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    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 2018. 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. THE ARTICLE MENTIONS ¿BLEEDING¿. HOW WAS THE BLEEDING CONTROLLED? DID THE PROCEDURE HAVE TO BE CONVERTED TO OPEN? DID THE PATIENT NEED TO HAVE A BLOOD TRANSFUSION? WERE YOU ABLE TO CONTROL THE BLEEDING? HOW DID YOU CONTROL THE BLEEDING? WHAT IS THE CURRENT STATUS OF THE PATIENT? DID THE PATIENT NEED ANY DIFFERENT TYPE OF POST OP CARE DUE TO THE BLEEDING/OOZING? 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: LONG-TERM FOLLOW-UP OF STARION VERSUS HARMONIC SCALPEL HEMORRHOIDECTOMY FOR GRADE III AND IV HERRHOIDS. AUTHOR: JOO HYUNG KIM, DAE HYUN KIM, YONG PYO LEE, KWANG WOOK SUH. CITATION: ASIAN JOURNAL OF SURGERY (2019) 42, 367E372 / HTTPS://DOI.ORG/10.1016/J.ASJSUR.2018.05.002. THE PURPOSE OF THIS RETROSPECTIVE STUDY FROM A PROSPECTIVELY DESIGNED DATABASE SYSTEM WAS TO DETERMINE THE DIFFERENCES IN TERMS OF THE EFFECTIVENESS IMMEDIATELY AFTER THE OPERATION AND 3 YEARS POST-OPERATIVELY BETWEEN STARION AND HARMONIC SCALPEL HEMORRHOIDECTOMY. FROM JAN 2011 TO OCT 2013, A TOTAL OF 221 PATIENTS WHO WERE DIAGNOSED WITH AT LEAST GRADE III MIXED HEMORRHOIDS WERE SELECTED IN THE STUDY. THE PATIENTS WERE RANDOMIZED INTO 2 GROUPS: SH GROUP (STARION HEMORRHOIDECTOMY) (N=114, N=74 MALE, N=40 FEMALE, MEAN AGE 46.08 ± 11.03 YEARS) AND HSH GROUP (HARMONIC SCALPEL HEMORRHOIDECTOMY) (N=107, N=65 MALE, N=42 FEMALE, MEAN AGE 48.78 ± 10.13 YEARS). IN HARMONIC SCALPEL HEMORRHOIDECTOMY, THE VERY FIRST STEP WAS TO GRAB A PORTION OF ANAL SKIN TAIL USING THE FORCEPS AND DISSECT THE HEMORRHOIDS WITHOUT DAMAGING THE ANAL SPHINCTER USING HARMONIC SCALPEL (ETHICON). BLEEDING WAS PREVENTED USING HARMONIC SCALPEL. POSTOPERATIVE COMPLICATIONS INCLUDED BLEEDING (N=1), ANAL SKIN TAG (N=2), PAIN (N=?) ¿WERE ADMINISTERED 10 MG OF KETOROLAC TROMETHAMINE 3 TIMES A DAY FOR 3 DAYS FROM THE DATE OF SURGERY; AND AS NEEDED, 30 MG OF KETOROLAC TROMETHAMINE WAS INJECTED AS AN INTRAVENOUS BOLUS ONCE OR TWICE ON THE DAY OF THE SURGERY; AND RECURRENCE (N=5). STARION WAS MORE ACCESSIBLE THAN HARMONIC SCALPEL WHILE NOT SHOWING ANY SIGNIFICANT DIFFERENCE IN TERMS OF POST-OPERATIVE PAIN SCORE, PATIENT SATISFACTION, WOUND HEALING, AND COMPLICATIONS. ADDITIONALLY, NO SIGNIFICANT DIFFERENCE WAS DETECTED IN THE RECURRENCE RATE DURING THE 3-YEAR POST-OPERATIVE FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418896 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 GENERATOR AND HANDPIECE.