BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA PROBE COVER

    MDR report key: 7452116 · Received April 23, 2018

    Report

    Report Number
    8043817-2018-00012
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Report Date
    March 28, 2018
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    KKX
    UDI-DI
    00748426073337
    PMA / PMN Number
    K882724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES OR PICTURES WERE RECEIVED FOR THIS INVESTIGATION. THE DHR WAS REVIEWED FOR LOT D171451 AND IT WAS CONFIRMED THAT THIS LOT HAD (B)(4) UNITS THAT WERE MANUFACTURED ON 05/25/2017. IT WAS ALSO CONFIRMED THAT NO DEFECTS WERE REPORTED DURING THE QUALITY INSPECTIONS. THE TRAINING RECORDS WERE REVIEWED AND IT WAS CONFIRMED THAT THE OPERATORS INVOLVED IN THE MANUFACTURE OF THIS LOT WERE PROPERLY TRAINED IN THE WORK INSTRUCTION REV THAT WAS RELEASED WHEN THE AFFECTED LOT WAS MANUFACTURED. ON (B)(6) 2018 RECEIVED A NOTIFICATION FROM THE CUSTOMER CONFIRMING THE PROBE TRANSDUCER WAS CREATING HOLES IN THE COVERS BECAUSE OF THE SHARP POINT. NO ACTIONS ARE BEING TAKEN AT THIS TIME SINCE THE NON-CONFORMANCE IS NOT RELATED TO THE MANUFACTURING PROCESS. THE CUSTOMER CONFIRMED THAT THE PRODUCT WAS AFFECTED BY THEIR PROBE TRANSDUCER. THIS IS REPORT 3 OF 3.

    Description of Event or Problem · 1

    MEDWATCH REPORT WAS RECEIVED ON (B)(6) 2018 WITH THE FOLLOWING INFORMATION: OVER THE PAST WEEK OR SO, THE OR NOTICED 4 SURGICAL PROBE COVERS THAT HAVE PIN HOLES. 4 DRAPES WERE SAVED, 3 PATIENT INFORMATION AVAILABLE (4TH DRAPE CAME WITH NO PATIENT INFORMATION). LOT NUMBERS ON 2 CASES CAN BE CONFIRMED AS SAME AND THE 3RD HAS A DIFFERENT LOT NUMBER. REFERENCE NUMBERS SAME ON THREE (A FOURTH DRAPE DOES NOT HAVE ANY MANUFACTURER/DEVICE INFORMATION). THIS DEVICE WAS NOTED TO HAVE BLOOD SEEPAGE INTO PROBE - IT IS BELIEVED THAT THE PROBE TOUCHED PATIENT'S SKIN DUE TO SMALL SIZE OF HOLE. 2 OF THE CASES WERE SENTINEL NODES BEING RETRIEVED AND PIN HOLES NOTED IN PROBE COVER WHEN CHECKED WITH SALINE AFTER THE CASE. A THIRD CASE WAS A BREAST BIOPSY. NO CASE DELAYS. NO PATIENT HARMS NOTED TO THIS POINT. OR TEAM KEEPING AN EYE ON ANY MORE PROBE COVERS WITH SIMILAR ISSUES. INTEGRITY OF STERILITY IS OR TEAM'S CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295625 GAMMA PROBE COVER PROBE COVER KKX MICROTEK DOMINICANA, S.A. GPC396 D171451 00748426073337

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR