BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSYNC

    MDR report key: 3874922 · Received June 11, 2014

    Report

    Report Number
    1319211-2014-00083
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OAB
    PMA / PMN Number
    K080376
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. TO DATE THE DEVICE HAS YET TO BE RETURNED. ATTEMPTS ARE BEING MADE TO OBTAIN THE DEVICE. AN INVESTIGATION INTO THE ROOT CAUSE FOR INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE SULIS ACCUSYNC (SERIAL NUMBER (B)(4)) NOTED NO REPAIRS, SERVICING AND/OR UPGRADES SINCE THE UNIT WAS MANUFACTURED. THE REVIEW CONFIRMS THAT THE UNIT MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2014, A (B)(6) FEMALE PATIENT PRESENTED FOR A LECD THERMAL ABLATION OF THE LIVER. DURING THE ABLATION, IT WAS NOTED THE PATIENT DEVELOPED ARTERIAL FIBRILLATION. THE TREATING PHYSICIAN DETERMINED TO CONTINUE WITH THE PROCEDURE. THERE WAS NO REPORT OF PERMANENT HARM OR INJURY TO THE PATIENT DUE TO THE EVENT. THE NANOKNIFE SYSTEM WAS REPORTED AS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344165 ACCUSYNC LECD THERMAL ABLATION SYSTEM OAB ANGIODYNAMICS 27200-5P

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention