BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9384668 · Received November 27, 2019

    Report

    Report Number
    3005075853-2019-23816
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    January 1, 2006
    Report Date
    October 31, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2006. 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: VIDEO-ASSISTED THYROIDECTOMY: INDICATIONS AND RESULTS. AUTHOR(S): PAOLO MICCOLI, PIERO BERTI, GIAN LUCA FRUSTACI, CARLO ENRICO AMBROSINI, GABRIELE MATERAZZI. CITATION: LANGENBECKS ARCH SURG. 2006; 391: 68¿71. DOI: 10.1007/S00423-006-0027-7. MINIMALLY INVASIVE VIDEO-ASSISTED THYROIDECTOMY (MIVAT) WAS SET UP AND INTRODUCED IN THE DEPARTMENT IN 1998. ITS RESULTS, AFTER AN ACCEPTABLE RELAPSE, CAN NOW BE EVALUATED, ALSO SPECULATING ON NEW POSSIBLE INDICATIONS. A TOTAL OF 833 PATIENTS UNDERWENT MIVAT SINCE JUNE 1998 (715 FEMALE AND 118 MALE PATIENTS). DURING THE SURGICAL PROCEDURE, HEMOSTASIS IS GUARANTEED BY A HARMONIC SCALPEL (ETHICON), USING EITHER CLIPS NOR LIGATURES. REPORTED COMPLICATIONS INCLUDED POST-OPERATIVE BLEEDING (N-1) WHICH REQUIRED RE-OPERATION. MIVAT CAN BE CONSIDERED A SAFE OPERATION OFFERING SIGNIFICANT COSMETIC ADVANTAGES WITH POSSIBLE NEW PROMISING INDICATIONS SUCH AS PROPHYLACTIC THYROIDECTOMY IN REARRANGED DURING TRANSFECTION (RET) GENE MUTATION CARRIERS. IT IS STILL LIMITED TO A MINORITY OF PATIENTS, IN PARTICULAR, IN ENDEMIC GOITRE COUNTRIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177409 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1