BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9624867 · Received January 23, 2020

    Report

    Report Number
    3005075853-2020-00520
    Event Type
    Injury
    Date Received
    January 23, 2020
    Report Date
    December 27, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 1/23/2020. DATE OF EVENT: PUBLICATION YEAR OF 2014. BATCH # UNK. 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. 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 STATED PATIENT EXPERIENCED "POSTOPERATIVE HEMORRHAGE." PLEASE CLARIFY WHAT WAS DONE TO TREAT OR CONTROL THE HEMORRHAGE? HOW IS THE PATIENT'S STATUS NOW?

    Description of Event or Problem · 1

    TITLE: EVALUATION OF TWO HEMORRHOIDECTOMY TECHNIQUES: HARMONIC SCALPEL AND FERGUSON¿¿S WITH ELECTROCAUTERY. AUTHOR/S: HAKAN BULUS, ADNAN TAS, ALI COSKUN, METIN KUCUKAZMAN. CITATION: ASIAN JOURNAL OF SURGERY. 2014; 37: 20-23. DOI: HTTP://DX.DOI.ORG/10.1016/J.ASJSUR.2013.04.002. THE PREVALENCE OF SYMPTOMATIC HEMORRHOIDAL DISEASE IS A COMMON DISEASE THAT USUALLY NEEDS SURGERY FOR TREATMENT. THE AUTHORS AIMED TO USE THE HARMONIC SCALPEL DEVICE (ETHICON; HS) FOR HEMORRHOIDECTOMY IN GRADE III AND GRADE IV HEMORRHOIDS AND COMPARE OUR RESULTS WITH FERGUSON¿¿S WITH ELECTROCAUTERY HEMORRHOIDECTOMY (FEH). ENROLLED INTO THE STUDY WERE 151 PATIENTS WHO WERE OPERATED FOR SYMPTOMATIC GRADE III AND IV HEMORRHOIDS. PATIENTS WERE RANDOMIZED INTO FEH (71 PATIENTS; AGE: 33.7 ± 8.4 YEARS) AND HS GROUPS (80 PATIENTS; AGE: 34.1 ± 9.2). IN THE HARMONIC SCALPEL (ETHICON) GROUP, HS WAS DEFINED AS EXCISION OF HEMORRHOID PEDICLE TO THE APEX REGION WITHOUT DAMAGING THE INTERNAL SPHINCTER WITH THE HELP OF VASCULAR FORCEPS. ANAL SPONGOSTAN WAS PLACED FOR BOTH PATIENT GROUPS TO CONTROL BLEEDING. IN THE HS GROUP, REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE HEMORRHAGE (N-2). CONVENTIONAL HEMORRHOIDECTOMY, INCLUDING OPEN AND CLOSED METHODS, IS ACCEPTED AS THE GOLD STANDARD FOR SURGICAL TREATMENT OF HEMORRHOIDS WORLDWIDE. IN CONCLUSION, HS HEMORRHOIDECTOMY IS PREFERRED FOR SURGICAL TREATMENT OF GRADE III OR GRADE IV HEMORRHOIDS. IT IS SAFE AND EFFECTIVE, AND CAUSES LESS BLOOD LOSS, POSTOPERATIVE PAIN, AND COMPLICATIONS COMPARED TO FEH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88074 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other