BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GENERATOR

    MDR report key: 11377997 · Received February 25, 2021

    Report

    Report Number
    1717344-2021-00302
    Event Type
    Injury
    Date Received
    February 25, 2021
    Date of Event
    November 8, 2016
    Report Date
    February 25, 2021
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE: HARMONIC SCALPEL IMPACT ON BLOOD LOSS AND OPERATING TIME IN MAJOR HEAD AND NECK SURGERY: A RANDOMIZED CLINICAL TRIAL. SOURCE: FRITZ ET AL. JOURNAL OF OTOLARYNGOLOGY - HEAD AND NECK SURGERY (2016) 45:58. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE STUDY DONE TO EVALUATE THE IMPACT OF USING THE HARMONIC SCALPEL ON OPERATING TIME AND BLOOD LOSS IN PATIENTS UNDERGOING RESECTION FOR ADVANCED ORAL CANCER (OSCC). THIRTY-SIX ADULT HEAD AND NECK CANCER PATIENTS WITH ADVANCED OSCC REQUIRING PRIMARY TUMOR RESECTION WITH UNI- OR BI- LATERAL SELECTIVE NECK DISSECTION FROM JULY 2012 TO SEPTEMBER 2014 WERE RANDOMIZED TO EITHER THE CONTROL GROUP (17 PATIENTS WITH CONVENTIONAL SURGERY, INCLUDING SCALPEL, SURGICAL TIES AND/OR CLIPS SUPPLEMENTED WITH THE UNIT'S BIPOLAR OR MONOPOLAR CAUTERY) OR THE EXPERIMENTAL GROUP (17 PATIENTS WITH NON-MEDTRONIC DEVICE SURGERY). 1 PATIENT IN THE CONVENTIONAL GROUP (WITH THE UNIT) HAD AN INTRAOPERATIVE INTERNAL JUGULAR VEIN COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276535 UNKNOWN GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN GENERATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other