BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOMCAT INSTRUMENT

    MDR report key: 22903587 · Received August 27, 2025

    Report

    Report Number
    2024800-2025-00058
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    July 28, 2025
    Report Date
    August 26, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    JQW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC WAS INFORMED THAT THE OPERATOR SUSPECTED THE MAGNETIC PHONE CASE IN THEIR POCKET MAY HAVE INADVERTENTLY TRIGGERED THE TOMCAT DOOR OPEN/CLOSE SENSORS WHEN THEY LEANED TOWARD THE INSTRUMENT TO CLEAR THE INITIAL ERROR, CAUSING THE DOORS TO REGISTER AS CLOSED AND THE PIPPAC GRIPPER ARM TO MOVE. A PICTURE OF THE OPERATOR¿S PHONE WITH PHONE CASE WAS PROVIDED TO HOLOGIC. HOLOGIC R&D TESTED THIS POSSIBILITY IN THE HOLOGIC LABORATORY BY HOLDING VARIOUS SIMILAR PHONES WITH PHONE CASES DIRECTLY AGAINST THE TOMCAT DOOR SENSOR. THIS TESTING WAS UNABLE TO TRIGGER THE DOOR OPEN/CLOSE SENSORS OR CAUSE THE PIPPAC GRIPPER ARM TO MOVE. HOLOGIC BELIEVES THAT THE INJURY WAS CAUSED BY THE OPERATOR NOT FOLLOWING ON-SCREEN INSTRUCTIONS AND OPENING THE ACCESS DOOR WHEN THE INSTRUMENT WAS PERFORMING ITS INITIALIZATION ROUTINE, AS SPECIFIED IN THE INITIAL REPORT. MOVEMENTS DURING INITIALIZATION ARE SIGNIFICANTLY SLOWER THAN DURING REGULAR OPERATION. IT IS UNKNOWN WHETHER THE PIPETTOR IMPACTED THE USER, OR IF A HASTY USER IMPACTED THE ARM.

    Additional Manufacturer Narrative · 0

    HOLOGIC THOROUGHLY REVIEWED THE TOMCAT INSTRUMENT LOGS AROUND THE TIME OF THE INCIDENT. INSTRUMENT LOGS INDICATE A PIPPAC ARM MOVE FAILURE DUE TO A MOTOR STALL ERROR ON (B)(6) 2025 AT APPROXIMATELY 7:33 AM EST. THE LOGS SHOW THE OPERATOR INCORRECTLY PRESSED THE CONFIRMATION BUTTON ON THE GUI INDICATING THAT THEY COMPLETED USER INTERVENTION STEPS. THIS CAUSED THE SYSTEM TO BEGIN INITIALIZING THE STALLED PIPPAC ARM. LOGS SHOWED THE OPERATOR OPENED THE CANOPY DOOR NEARLY SIMULTANEOUSLY (0.019 SECONDS) AFTER THE PIPPAC ARM BEGAN ITS INITIALIZATION MOVEMENT. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. FURTHER INVESTIGATION IS ONGOING. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE OUTCOMES RELATED TO THIS ISSUE.

    Description of Event or Problem · 0

    FOLLOW-UP REPORT. SEE SECTION H11.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC THAT AN EMPLOYEE WAS INJURED BY THE UNEXPECTED MOVEMENT OF THE PIPPAC ARM INSIDE THE TOMCAT INSTRUMENT. CUSTOMER REPORTED THAT ON (B)(6) 2025 AT APPROXIMATELY 7:30 AM EST THERE WAS A E28 "FAILED TO UNCAP" ERROR, PROMPTING THE OPERATOR TO OPEN BOTH CANOPY DOORS AND ACCESS THE PROCESSING STATION TO REMOVE DEBRIS. WHEN THE OPERATOR REACHED INTO THE INSTRUMENT TO REMOVE DEBRIS, THE PIPPAC ARM MOVED TO THE PROCESSING STATION AND INJURED THE OPERATOR. THE OPERATOR WAS WEARING A LAB COAT BUT STILL SUFFERED A THREE-INCH SHALLOW LACERATION ON THE RIGHT FOREARM. THE OPERATOR CLEANED THE WOUND AND APPLIED GAUZE, AND THE OPERATOR RETURNED TO WORK IMMEDIATELY. CUSTOMER STATED THAT THEY CREATED AN INCIDENT REPORT. HOLOGIC HAS NOT BEEN INFORMED OF ANY FURTHER TREATMENT OR ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467820 TOMCAT INSTRUMENT STATION, PIPETTING AND DILUTING, FOR CLINICAL USE JQW HOLOGIC, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other