BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK, GAMMA PROBE COVER

    MDR report key: 5046384 · Received January 8, 2015

    Report

    Report Number
    8043817-2014-00010
    Event Type
    Malfunction
    Date Received
    January 8, 2015
    Report Date
    December 13, 2014
    Manufacturer
    MICROTEK DOMINICAN, S.A.
    Product Code
    KKX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW FOR COMPLAINTS FOR PRODUCT NUMBER GPC396EU WAS COMPLETED. ONE COMPLAINT WAS REPORTED IN (B)(6) ON (B)(6) 2012. IT WAS INCONCLUSIVELY RESOLVED DUE TO A SAMPLE EVALUATION THAT FOUND NO DEFECT. ROOT CAUSE OF THE INCIDENT WAS NOT DEFINED. CASE CLOSED IN 2012. NO COMPLAINTS HAVE BEEN REPORTED RELATING TO PRODUCT NO. GPC396EU WHICH IS DISTRIBUTED IN THE US. THE DISTRIBUTOR IN (B)(6) HAS ASKED CUSTOMERS TO RETURN PRODUCTS THAT HAVE THE SAME NUMBER AS THE ONE REPORTED. NO INCIDENTS HAVE BEEN REPORTED INVOLVING OTHER LOT NUMBERS. ONE SAMPLE IS IN THE PROCESS OF BEING RETURNED TO ECOLAB-MICROTEK SO FAR. NONE OF THE END CUSTOMERS COULD IDENTIFY EXACTLY WHAT WAS WRONG WITH THE PROBE COVERS; THE PROCEDURE ITSELF IS BLOODY AND IT'S DIFFICULT TO IDENTIFY ANY GAPS, TEARS, OR OTHER DEVIATIONS TO THE DEVICE. ADDL. INVESTIGATIONS OF THESE INCIDENTS WILL BE CONDUCTED. RETURNED PRODUCT FOR LOT NUMBER D133381, PART NUMBER GPC396EU WILL BE FURTHER INVESTIGATED. THIS REPORT IS AN INITIAL REPORT FOR 30 DAYS. ECOLAB-MICROTEK WILL SUBMIT ANY FOLLOW-UP REPORT WITHIN ONE MONTH OF THE DAY THE INFO IS RECEIVED AS THE ROOT CAUSE DETERMINATION AND INVESTIGATION OF THE INCIDENTS CONTINUES.

    Description of Event or Problem · 1

    THE FOLLOWING INCIDENTS IN ((B)(6)) WERE REPORTED TO ECOLAB-MICROTEK ON (B)(6) 2014, BY ONE DISTRIBUTOR, REGARDING PROBE COVER PRODUCT NO. GPC396EU, LOT NO. D13338. ALL PRODUCT WAS DISTRIBUTED IN (B)(6). THERE WAS NO PATIENT INJURY REPORTED FOR ANY OF THE INCIDENTS. NO TREATMENT WAS REPORTED, HOWEVER, ONE CUSTOMER IN SPAIN HAD GIVEN THE PATIENT ANTIBIOTICS AS A PRECAUTION. ALL INCIDENTS HAVE BEEN OBSERVED DURING SENTINEL LYMPH NODE BIOPSIES FOR BREAST CANCER PATIENTS. (B)(6): ONE CUSTOMER REPORTED TWO INCIDENTS TO THE DISTRIBUTOR. THE CUSTOMER DISCOVERED BLOOD ON THE PROBE COVER AFER USING PRODUCT GPC396EU. THE NEXT DAY, THE SAME CUSTOMER FOUND BLOOD ON ANOTHER PROBE COVER, GPC396EU ATER USE. (B)(6): ONE CUSTOMER REPORTED ONE INCIDENT TO THE DISTRIBUTOR. THE CUSTOMER DISCOVERED BLOOD ON THE PROBE COVER AFTER USING PRODUCT GPC396EU. (B)(6): TWO CUSTOMERS REPORTED TO THE DISTRIBUTOR THAT THERE WERE SEVERAL INCIDENTS. THE CUSTOMER DISCOVERED BLOOD ON THE PROBE COVER AFTER USING PRODUCT GPC396EU. ONE CUSTOMER IN (B)(6), AFTER IDENTIFYING THE BLOOD ON THE PROBE COVER HAD GIVEN HE PATIENT ANTIBIOTICS AS A PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20124 MICROTEK, GAMMA PROBE COVER PROBE COVERS KKX MICROTEK DOMINICAN, S.A. GPC396EU D133381

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK