BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE

    MDR report key: 3170263 · Received June 14, 2013

    Report

    Report Number
    3005075853-2013-03016
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT ADDITIONAL INFORMATION REQUESTED: HAS THE SURGEON BEEN IN-SERVICED ON HEAT MANAGEMENT? IS THE SURGEON AWARE OF THE WARNINGS IN THE IFU AS TO HEAT? WAS THE THYROIDECTOMY A TOTAL THYROIDECTOMY? HOW LONG AFTER THE THYROIDECTOMY DID THE PATIENT PRESENT WITH THE VOCAL CORD PARALYSIS? WHAT DID THE PATIENT PRESENT WITH? POSTOPERATIVE HOARSENESS OR BREATHINESS. BIPHASIC STRIDOR, RESPIRATORY DISTRESS, OR BOTH. AIRWAY SIGNS IN THE IMMEDIATE POSTOPERATIVE PERIOD. DYSPNEA OR STRIDOR WITH EXERTION. AN INABILITY TO CREATE A HIGH-PITCHED SOUND. WAS THE PATIENT DIAGNOSED WITH LARYNGEAL NERVE DAMAGE? WAS THE PATIENT DIAGNOSED WITH UNILATERAL VOCAL FOLD PARALYSIS? WAS THE PATIENT DIAGNOSED WITH BILATERAL VOCAL-FOLD PARALYSIS WHAT TYPE OF DAMAGED WAS THE PATIENT DIAGNOSED WITH? COMPLETE OR PARTIAL TRANSECTION. TRACTION, CONTUSION, CRUSH, BURN, MISPLACED LIGATURE, COMPROMISED BLOOD SUPPLY. WHICH NERVE WAS DAMAGED: RECURRENT LARYNGEAL NERVE (RLN) - RESULTS IN A TRUE VOCAL-FOLD PARESIS OR PARALYSIS. SUPERIOR LARYNGEAL NERVE (SLN). WHEN DIAGNOSED, DID THE PATIENT HAVE A FIBEROPTIC LARYNGOSCOPY PERFORMED? DID THE PATIENT RECEIVE A LARYNGEAL ELECTROMYOGRAPHY (EMG) TO DISTINGUISH VOCAL FOLD PARALYSIS FROM INJURY TO THE CRICOARYTENOID JOINT SECONDARY TO INTUBATION. WHAT IS THE PATIENT¿S CURRENT CONDITION? WHAT TREATMENT WILL BE PATIENT BE RECEIVING? WHAT HEAT MITIGATIONS TAKEN INTRAOPERATIVELY? WERE THERE ANY COMPLICATIONS INTRA-OPERATIVELY THAT LEAD THE SURGEON TO BELIEVE THAT THE BLADE WAS HOTTER THAN NORMAL? WHAT WAS THE MEDICALLY NECESSARY REASON FOR THE TRACHEOTOMY?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A THYROIDECTOMY PROCEDURE IT WAS OBSERVED A PARALYSIS OF THE VOCAL CORDS AND CONSEQUENT TRACHEOTOMY. THE PROCEDURE WAS TOTALLY CARRIED OUT WITH THE DEVICE AS THE PROBLEM WAS ONLY NOTICED AFTER THE AWAKENING OF THE PATIENT. DEVICE HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272037 ULTRACISION HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK K4C84U

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE