BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS GAMMA PROBE COVER

    MDR report key: 6804885 · Received August 18, 2017

    Report

    Report Number
    8043817-2017-00021
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Date of Event
    July 7, 2017
    Report Date
    July 19, 2017
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    KKX
    UDI-DI
    00748426076451
    PMA / PMN Number
    K882724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR WAS REVIEWED FOR LOT D161671 AND IT WAS NOTICED THAT THIS LOT HAD 800 PIECES THAT WERE MANUFACTURED FROM 06/16/16 TO 06/18/16. NO DEFECTS RELATED TO THE NON CONFORMANCE WERE REPORTED DURING QUALITY INSPECTION. AT THE TIME OF THIS REPORT, NO SAMPLE HAD BEEN PROVIDED. AS NO DEVICE WAS AVAILABLE FOR EVALUATION, THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE END USER IS REPORTING: STERILE PROBE COVER USED TO COVER UNSTERILE PROBE DURING SURGERY. POST PROCEDURE WHEN PROBE COVER REMOVED THERE WAS BLOOD ON THE PROBE. ON INSPECTION BLOOD SEEPED THROUGH SEAMS AND MICRO HOLE IN COVER. NO VISIBLE HOLE PRESENT. THE SAME THING HAPPENED IN JUNE. ALL PROBE COVERS OF THAT LOT NUMBER ARE PULLED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583670 CORDLESS GAMMA PROBE COVER PROBE COVER KKX MICROTEK DOMINICANA, S.A. GPC415 D161671 00748426076451

    Patients

    Seq Age Sex Outcome Treatment
    1