BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NANOKNIFE SINGLE ELECTRODE PROBE, 15 CM

    MDR report key: 2492597 · Received March 12, 2012

    Report

    Report Number
    1319211-2012-00017
    Event Type
    Injury
    Date Received
    March 12, 2012
    Date of Event
    February 2, 2012
    Report Date
    March 7, 2012
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT REPORTED. A SHIP HISTORY REVIEW WAS CONDUCTED ON THE REPORTED CATALOG NUMBER. THIS COMPLAINT HAS RECEIVED THE FOLLOWING LOTS OF THE REPORTED CATALOG NUMBER (LOTS 110318 AND 110310). THE INCOMING RECORDS FOR IRE SINGLE ELECTRODE PROBE, 15 CM CATALOG NUMBER 20400101 LOT NUMBERS 110318 AND 110310 WERE REVIEWED. THIS PRODUCT WAS MANUFACTURED TESTED AND RELEASED ACCORDING TO SPECIFICATION. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION AND ANY FOLLOW UP INFO WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE USER ON (B)(6) 2012, A MALE PT OF UNK AGE, PRESENTED FOR A NANOKNIFE ABLATION OF A METASTATIC HCC LESION IN THE ABDOMINAL CAVITY. THE LESION SITUATED BETWEEN THE SPLEEN, LEFT KIDNEY AND THE SMALL BOWEL. IT WAS REPORTED BY THE TREATING PHYSICIAN ON (B)(6) 2012 THAT THE PT WAS EXPERIENCING MELENA. FOLLOW UP WITH THE TREATING PHYSICIAN ON(B)(6) 2012, NOTED THAT PT RESPONDED WELL TO THE ABLATION AND PRESENTS NO EVIDENCE OF INJURY TO SURROUNDING STRUCTURE. OTHER THAN A FEW DAYS OF MILD MELENA, THE PT NEVER EXPERIENCED ANY OTHER SYMPTOMS OR COMPLICATIONS. THERE WAS NO REPORT OF PERMANENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NANOKNIFE SINGLE ELECTRODE PROBE, 15 CM TISSUE ABLATION SYSTEM GEI ANGIODYNAMICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other