BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERAL PURPOE PROBE COVER

    MDR report key: 5158595 · Received October 18, 2015

    Report

    Report Number
    8043817-2015-00005
    Event Type
    Malfunction
    Date Received
    October 18, 2015
    Date of Event
    September 16, 2015
    Report Date
    October 16, 2015
    Manufacturer
    ECOLAB MICROTEK
    Product Code
    KKX
    PMA / PMN Number
    K882724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS COMPLETED AT THE MANUFACTURING SITE IN THE (B)(4). BASED ON THE DHR REVIEWED, THIS LOT HAD (B)(4) PIECES AND IT WAS MANUFACTURED ON 7/16/2015. NO DEFECTS WERE REPORTED DURING PROCESSING, PACKAGING OR FINAL INSPECTION. THE INVESTIGATION REVEALED THAT THIS PROBLEM WAS NOT DUE TO AN ASSEMBLY, MATERIAL, OR PROCESS ISSUES. NO DEFECTIVE PRODUCT HAS BEEN RETURNED TO MANUFACTURER FOR EVALUATION. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2015- END USER (PHYSICIAN) HAS REPORTED MEDWATCH (B)(4) TO THE FDA AND STATED THAT DURING THE PROCEDURE FOR THE RIGHT BREAST LUMPECTOMY, THE END USER FOUND CONTAMINATION (BLOOD) INSIDE THE PROBE COVER DURING THE PROCEDURE. END USER CHECKED VERY CAREFULLY AND FOUND A SMALL HOLE AT THE SEAM OF COVER. A SMALL HOLE COULD HAVE BEEN PRESENT PRIOR TO USE OR COULD BEEN A WEAK SPOT THAT OPENED WITH USE. ON THE SAME DAY THAT THE END USER REPORTED THIS TO MEDWATCH, THERE WERE COMPLAINTS OF TWO INSTANCES OF GROSS CONTAMINATION FROM THE NEOPROBE HANDLE AND POSSIBLY EFFECTED STERILITY. THERE WAS NO PATIENT INJURY REPORT OF ADDITIONAL TREATMENT. PRODUCT NUMBER PC1419, LOT NUMBER REPORTED WAS D151951.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689015 GENERAL PURPOE PROBE COVER PROBE COVER KKX ECOLAB MICROTEK PC1419 D151951

    Patients

    Seq Age Sex Outcome Treatment
    1