BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9485192 · Received December 17, 2019

    Report

    Report Number
    3005075853-2019-24502
    Event Type
    Injury
    Date Received
    December 17, 2019
    Report Date
    November 26, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2017. 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 : PAROTIDECTOMY USING THE HARMONIC SCALPEL: TEN YEARS OF EXPERIENCE AT A RURAL ACADEMIC HEALTH CENTER. AUTHOR : MARC A. POLACCO1,2*, ANDREW M. PINTEA1, BENOIT J. GOSSELIN1 AND JOSEPH A. PAYDARFAR1. CITATION: POLACCO ET AL. HEAD & FACE MEDICINE (2017) 13:8. DOI 10.1186/S13005-017-0141-5. THE OBJECTIVE OF THIS RETROSPECTIVE COHORT IS TO COMPARE OPERATIVE TIME, BLOOD LOSS, COMPLICATIONS, AND COST BETWEEN THE HARMONIC SCALPEL AND STEEL SCALPEL PLUS BIPOLAR CAUTERY FOR SUPERFICIAL AND TOTAL PAROTIDECTOMY. A TOTAL OF 255 PATIENTS UNDERWENT SUPERFICIAL OR TOTAL PAROTIDECTOMY WITH THE HARMONIC (HS) (ETHICON, SOMERVILLE, NJ) OR COLD STEEL BETWEEN 2000 AND 2015. SUPERFICIAL PAROTIDECTOMY WAS PERFORMED ON 120 PATIENTS (64 FEMALES AND 56 MALES) WITH HS AND 54 (30 FEMALES AND 24 MALES) WITH STEEL SCALPEL PLUS BIPOLAR CAUTERY (SB). TOTAL PAROTIDECTOMY WAS PERFORMED ON 59 PATIENTS (28 FEMALES AND 31 MALES) USING HS AND 22 PATIENTS (12 FEMALES AND 10 MALES) WITH SB. THE MEAN AGE (YEARS) FOR PATIENTS WHO UNDERWENT SUPERFICIAL PAROTIDECTOMY WAS 59 ± 14 FOR HS AND 56 ± 15 FOR SB. THE MEAN AGE (YEARS) WHO UNDERWENT TOTAL PAROTIDECTOMY WAS 56 ± 15 FOR HS AND 55 ± 14 FOR SB. THE COMPLICATIONS NOTED UNDER SUPERFICIAL PAROTIDECTOMY (HS) WERE AURICULAR NUMBNESS (N=7), TRANSIENT FACIAL PARESIS (N=1), AND SEROMA (N=1). THE COMPLICATIONS NOTED UNDER TOTAL PAROTIDECTOMY (HS) WERE AURICULAR NUMBNESS (N=5), TRANSIENT FACIAL PARESIS (N=1), AND PERMANENT FACIAL PARESIS (N=1). IN CONCLUSION, THE AUTHORS REPORTED THAT THE HARMONIC SCALPEL DECREASES BLOOD LOSS AND OPERATING TIME FOR SUPERFICIAL AND TOTAL PAROTIDECTOMY. SHORTER OPERATIVE TIMES MAY DECREASE THE OVERALL COST OF PAROTIDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272189 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other