BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PMTA ACCU21 STANDARD APPLICATOR

    MDR report key: 5427333 · Received February 4, 2016

    Report

    Report Number
    1319211-2016-00009
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Date of Event
    January 5, 2016
    Report Date
    January 5, 2016
    Manufacturer
    ANGIODYNAMICS.
    Product Code
    NEY
    PMA / PMN Number
    K122762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION AND ANY FOLLOW UP INFORMATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED LOT FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 1

    RETURNED FOR EVALUATION WAS ONE PMTA ACCU2I STANDARD APPLICATOR. A VISUAL EXAMINATION OF THE DEVICE NOTED THE TUBING WAS CUT (THE CARTRIDGE WAS NOT RETURNED) AND THE TIP WAS BENT APPROX. 10 DEGREES BUT STILL FULLY ATTACHED. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF THE TIP OF THE APPLICATOR BEING BENT IS CONFIRMED. ALTHOUGH THE COMPLAINT DESCRIPTION IS CONFIRMED, A DEFINITIVE ROOT CAUSE FOR THE EVENT CANNOT BE DETERMINED. A POSSIBLE CONTRIBUTING FACTOR COULD HAVE BEEN HANDLING DAMAGE; I.E. LATERAL FORCES ON THE APPLICATOR TIP. IT IS POSSIBLE THAT THE PATIENT MOVING DURING THE PROCEDURE WHILE THE APPLICATOR WAS IN PLACE COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO WITH CATALOG NUMBER, CONTAINS A STATEMENT "ALWAYS ADVANCE THE APPLICATOR INTO THE TARGET TISSUE USING AXIAL FORCES ONLY. AVOID PLACING LATERAL FORCES ON THE APPLICATOR TIP DURING PLACEMENT OR REMOVAL" AND LATERAL FORCES ON THE APPLICATOR TIP SHOULD BE AVOIDED BOTH DURING INSERTION AND REMOVAL. FAILURE TO DO SO COULD RESULT IN DAMAGE TO THE MICROWAVE ARRAY, FAILURE OF THE APPLICATOR AND INJURY TO THE PATIENT." A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, (B)(6) 2016, PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR A MICROWAVE PROCEDURE OF THE LIVER. DURING THE PROCEDURE, AFTER WITHDRAWAL, THE TREATING PHYSICIAN NOTED THE TIP OF THE APPLICATOR PROBE WAS BENT. THE TIP OF THE APPLICATOR HAD NOT DETACHED FROM THE SHAFT OF THE PROBE AND NO WIRES WERE EXPOSED. THE DEVICE WAS SET ASIDE AND A NEW OF THE SAME DEVICE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. IT WAS THE PATIENT SUFFERED NO HARM OR INJURY DUE TO THE EVENT. THE REPORTED DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68859 PMTA ACCU21 STANDARD APPLICATOR NEY ANGIODYNAMICS.

    Patients

    Seq Age Sex Outcome Treatment
    1