BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9485182 · Received December 17, 2019

    Report

    Report Number
    3005075853-2019-24481
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    January 1, 2004
    Report Date
    November 21, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2004. MEDICAL DEVICE: 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.

    Description of Event or Problem · 1

    TITLE: A DOUBLE-BLIND, RANDOMIZED TRIAL COMPARING LIGASURE AND HARMONIC SCALPEL HEMORRHOIDECTOMY. AUTHOR/S: S. Y. KWOK, F.R.A.C.S., F.R.C.S.(EDINB.), C. C. CHUNG, F.R.C.S.(EDINB.),1. K. K. TSUI, M.R.C.S.(EDINB.),1 M. K. W. LI, F.R.C.S.(ENGL.), F.R.C.S.(EDINB.)1. CITATION: DIS COLON RECTUM 2005; 48: 344¿348; DOI: 10.1007/S10350-004-0845-Z. THIS DOUBLE-BLIND, RANDOMIZED CONTROLLED TRIAL AIMED TO COMPARE THE OUTCOMES OF LIGASURE HEMORRHOIDECTOMY AND HARMONIC SCALPEL HEMORRHOIDECTOMY. FROM FEBRUARY 2002 TO NOVEMBER 2003, A TOTAL OF 49 PATIENTS WITH GRADE 3 AND 4 HEMORRHOIDS ADMITTED FOR HEMORRHOIDECTOMY WERE SELECTED AND RANDOMIZED INTO TWO GROUPS: LIGASURE HEMORRHOIDECTOMY (LSH) (N=24) OR HARMONIC SCALPEL HEMORRHOIDECTOMY (HSH) (N=25: N=13 MALES N=12 FEMALES, MEDIAN AGE: 49.4 YEARS, AGE RANGE: 33-75). THE HEMORRHOID BUNDLE WAS DISSECTED OFF THE INTERNAL SPHINCTER USING THE HARMONIC SCALPEL (ETHICON). PEDICLE CONTROL WAS ACHIEVED USING THE SAME DEVICE AND WOUNDS WERE LEFT OPEN. COMPLAINTS INCLUDED POSTOPERATIVE PAIN (N=13). DOLOGESIC WAS GIVEN AS TREATMENT FOR THE PATIENTS. MEDIAN PAIN SCORE WAS REPORTED TO BE 4.8. OTHER COMPLICATIONS WERE HEMORRHAGE (N=1), MILD RECTAL BLEEDING (N=1) AND A FLATUS INCONTINENCE (N=1). THERE WERE TWO UNSCHEDULED READMISSIONS OCCURRED IN THE HSH GROUP. ONE PATIENT HAD SIGNIFICANT POSTOPERATIVE PAIN, AND THE OTHER HAD MILD RECTAL BLEEDING. NO SURGICAL INTERVENTIONS WERE REQUIRED. IN CONCLUSION, LIGASURE HEMORRHOIDECTOMY IS SAFE AND EFFECTIVE. IT HAS A SHORTER OPERATING TIME AND PRODUCES LESS POSTOPERATIVE PAIN THAN HARMONIC SCALPEL HEMORRHOIDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272207 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other