BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDLESS GAMMA PROBE COVER

    MDR report key: 6001406 · Received October 5, 2016

    Report

    Report Number
    3006581049-2016-00014
    Event Type
    Injury
    Date Received
    October 5, 2016
    Report Date
    September 9, 2016
    Manufacturer
    MICROTEK MEDICAL MALTA LIMITED
    Product Code
    KKX
    PMA / PMN Number
    K882724
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO SAMPLES WERE RECEIVED FROM BATCH (B)(4). VISUAL INSPECTION OF THE RECEIVED SAMPLES VERSUS THE MASTER REFERENCE SAMPLE YIELDED NO VISUAL DEFECTS. BOTH PROBE COVERS WERE FILLED WITH 500ML OF METHYLENE BLUE SOLUTION AND LEFT HANGING FOR 30 SECONDS. A VISUAL INSPECTION OF LEAKS BETWEEN THE SEALED FILM AND/OR THROUGH THE FILM WAS PERFORMED AND NO LEAKS WERE NOTED. BATCH RECORD REVIEW OF THE ABOVE MENTIONED BATCHES WAS PERFORMED AND NO NON-CONFORMITIES SIMILAR TO THE DEFECT REFERENCED IN THE COMPLAINT WAS NOTED DURING THE IN-PROCESS INSPECTIONS THAT WERE PERFORMED. BASED UPON THE TESTING OF RETURNED SAMPLES AND REVIEW OF BATCH RECORDS, THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. ADDITIONALLY, A FOLLOW UP QUESTIONNAIRE WAS RECEIVED FROM THE HOSPITAL STATED THAT 15 ADDITIONAL INCIDENTS HAVE HAPPENED WITH THE PRODUCT OVER THE PAST 3 MONTHS. THIS IS REPORT 13 OF 16.

    Description of Event or Problem · 1

    (B)(6). DATE OF EVENT: BEST ESTIMATE (B)(6) 2016. ACCORDING TO THE INFORMATION RECEIVED, WHEN USING THE METAL GAMMA PROBE WITH THE GPC PROBE COVER, THE METAL IS BLOODY WHEN THEY PULL THEM OUT OF THE PATIENT. THE COVERS ARE PERMEABLE/LEAKY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650618 CORDLESS GAMMA PROBE COVER PROBE COVER KKX MICROTEK MEDICAL MALTA LIMITED GPC415EU 1611782V,1410156V,1610858V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other