BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FECAL EXTRACTION DEVICE

    MDR report key: 15950317 · Received December 9, 2022

    Report

    Report Number
    2026994-2022-00001
    Event Type
    Injury
    Date Received
    December 9, 2022
    Date of Event
    September 29, 2020
    Report Date
    November 9, 2022
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Product Code
    NXO
    UDI-DI
    08426950846833
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS REMINDED OF PROPER DEVICE OPENING TECHNIQUE, AS DETAILED IN THE PRODUCT DIRECTION INSERT. THE CUSTOMER WAS REMINDED TO FOLLOW THE INSTRUCTIONS CAREFULLY TO ENSURE PROPER AND COMFORTABLE REMOVAL OF THE DEVICE CAPS. THE CUSTOMER WAS ALSO SENT SPECIAL TOOLS TO ASSIST WITH OPENING THE DEVICE. THE TOOLS ADD AN ADDITIONAL GRIPPING AREA, WHICH REDUCES THE STRAIN ON THE OPERATOR WHEN OPENING A LARGE NUMBER OF DEVICES.

    Description of Event or Problem · 0

    ON (B)(6)2022, THE PATIENT (SPECIAL CHEMISTRY TECHNOLOGIST, HEALTHCARE PROFESSIONAL) FILED A SUPERVISOR'S INCIDENT INVESTIGATION AT LABCORP REPORTING RIGHT ARM HAND PAIN AND NUMBNESS. THE INJURY WAS SUSPECTED TO BE DUE TO THE CONTINUAL REPETITIVE MOTION OF PERFORMING BIOLOGICAL SAMPLE EXTRACTIONS. THE PATIENT ONLY RAN CALPROTECTIN TESTING AND HAD DIFFICULTY USING THE FECAL EXTRACTION DEVICE. THE EMPLOYEE REPORTED HANDLING BETWEEN 600-900 SAMPLES IN A SINGLE SHIFT, USING THE SAME REPETITIVE MANUAL MOTION. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR FURTHER MEDICAL EVALUATION BY ORTHOPEDIC STAFF AT THAT TIME. THIS INCIDENT WAS NOT REPORTED TO INOVA DIAGNOSTICS AT THIS TIME. ON (B)(6)2022, INOVA DIAGNOSTICS WAS CONTACTED BY THE LABCORP OF AMERICA CUSTOMER AGAIN TO REQUEST SPECIAL TOOLS TO AID IN OPENING A HIGH VOLUME OF FECAL EXTRACTION DEVICES. THEY REPORTED THAT THE FECAL EXTRACTION DEVICE VOLUME HAD GROWN AS THE LABORATORY IS PROCESSING OVER 25,000 SAMPLES PER MONTH. THERE WERE NO PERMANENT WRIST INJURIES OR CARPAL TUNNEL DIAGNOSES REPORTED WITH CURRENT USERS, HOWEVER, THE INJURY THAT OCCURRED IN 2020 WAS SHARED WITH INOVA DIAGNOSTICS AT THIS TIME AS EVIDENCE OF A PAST INJURY WHICH REQUIRED INTERVENTION (SEE (B)(6) 2020 DESCRIPTION, ABOVE). THE CUSTOMER SPECIFIED THAT THE INJURY WAS LATER DIAGNOSED AS CARPAL TUNNEL SYNDROME AND THE TECHNOLOGIST WAS TRANSFERRED TO ANOTHER DEPARTMENT TO PREVENT FURTHER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2908863 FECAL EXTRACTION DEVICE Calprotectin, fecal NXO INOVA DIAGNOSTICS, INC. 504837 08426950846833

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention