BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9533263 · Received December 30, 2019

    Report

    Report Number
    3005075853-2019-24809
    Event Type
    Injury
    Date Received
    December 30, 2019
    Date of Event
    January 1, 2018
    Report Date
    December 6, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 12/30/2019. DATE OF EVENT: PUBLICATION YEAR OF 2018. 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. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    TITLE : COMPARISON OF SURGICAL TECHNIQUES FOR BENIGN PAROTID TUMOURS: A MULTICENTRE RETROSPECTIVE STUDY. AUTHOR : C. Y. ZHENG, R. CAO, M. H. GAO, Z. Q. HUANG, M. C. SHENG, YONGJIE HU. CITATION: INT. J. ORAL MAXILLOFAC. SURG. 2019; 48: 187¿192. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO INVESTIGATE THE SURGICAL VARIABLES, POSTOPERATIVE COMPLICATIONS, AND RECURRENCE RATES OF THREE DIFFERENT PROCEDURES FOR BENIGN PAROTID TUMOURS. DURING THE YEARS 2012 TO 2016, 281 PATIENTS WITH HISTOLOGICALLY CONFIRMED BENIGN TUMOUR LOCATED IN THE SUPERFICIAL PAROTID GLAND UNDERWENT PAROTIDECTOMY AND WERE DIVIDED INTO THREE GROUPS BASED ON THE TECHNIQUE: SUPERFICIAL PAROTIDECTOMY (N=98; N=53 MALE AND N=45 FEMALE; MEAN AGE OF 48±19YEARS); PARTIAL SUPERFICIAL PAROTIDECTOMY (N=91; N=49 MALE AND N=42 FEMALE; MEAN AGE OF 29±16 YEARS); AND ULTRASONIC SCALPEL-ASSISTED MINIMALLY EXTRACAPSULAR DISSECTION (US-MECD) (N=49 MALE AND N=43 FEMALE; MEAN AGE OF 49±17 YEARS). IN THE US-MECD GROUP, ULTRASONIC SCALPEL (HARMONIC SYSTEM; ETHICON ENDO-SURGERY, LLC, (B)(4), USA) WAS USED WHERE TUMOUR WAS CAREFULLY MOBILIZED WITH THE ULTRASONIC SCALPEL EXACTLY OUTSIDE OF THE CAPSULE, ENSURING THAT ANY TISSUE THAT IS CUT DOES NOT HAVE A FACIAL NERVE BRANCH REMAINING WITHIN IT. INTRAOPERATIVELY, TWO PATIENTS FROM US-MECD GROUP HAD RUPTURED TUMOR CAPSULE WHICH WERE MANAGED WITH THOROUGH IRRIGATION AND METICULOUS REMOVAL OF ANY TUMOR PARTICLES. POSTOPERATIVE OUTCOME IN US-MECD GROUP INCLUDED DECREASED SENSATION (N=27), AND TRANSIENT FACIAL NERVE PARALYSIS (N=5) IN WHICH 3 PATIENTS HAD FULL RECOVERY BETWEEN 1 TO 6 MONTHS AFTER SURGERY. AT 1 YEAR AFTER SURGERY, COMPLICATIONS IN US-MECD GROUP INCLUDED DECREASED SENSATION (N=3) AND PERMANENT FACIAL NERVE PARALYSIS (N=2). NO SIGNIFICANT DIFFERENCE IN WOUND INFECTION, SIALOCELE, OR PERMANENT FACIAL NERVE PARALYSIS WAS OBSERVED AMONG THE THREE GROUPS. PATIENTS ENROLLED DURING 2012¿2013 WERE SELECTED TO EVALUATE THE RECURRENCE RATES, AND NO STATISTICALLY SIGNIFICANT DIFFERENCES WERE FOUND AMONG THE GROUPS. IN CONCLUSION, US-MECD SHOWED SIMILAR EFFECTIVENESS AND FEWER SIDE EFFECTS THAN SUPERFICIAL PAROTIDECTOMY AND PARTIAL SUPERFICIAL PAROTIDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323577 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other