BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PMTA ACCU2I STANDARD APPLICATOR

    MDR report key: 3800265 · Received May 1, 2014

    Report

    Report Number
    1319211-2014-00060
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    NEY
    PMA / PMN Number
    K122762
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVAL. THE FIRM IS ATTEMPTING TO OBTAIN THE DEVICE. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVAL WILL BE SENT VIA A FOLLOW UP MEDWATCH. A REVIEW OF THE LOT HISTORY RECORDS FOR THE REPORTED LOT WAS PERFORMED FOR ANY DEVIATIONS. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(4)2014, A MALE PT OF UNK AGE PRESENTED FOR A MICROWAVE PROCEDURE OF THE LIVER. WHEN THE TREATING PHYSICIAN WITHDREW THE PROBE TO REPOSITION, IT WAS NOTED THE TIP OF THE APPLICATOR HAD FRACTURED OFF INSIDE OF THE PT. THE PHYSICIAN DETERMINED NOT TO REMOVE THE FRACTURE PIECE FROM THE PT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF PERMANENT HARM OR INJURY TO THE PT DUE TO THE EVENT. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260975 PMTA ACCU2I STANDARD APPLICATOR MICROWAVE APPLICATOR NEY ANGIODYNAMICS 114030237

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention