BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVICAL SEAL ASSY DEVICE

    MDR report key: 21635607 · Received March 18, 2025

    Report

    Report Number
    1222780-2025-00127
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    February 20, 2025
    Report Date
    March 18, 2025
    Manufacturer
    HOLOGIC, INC
    Product Code
    QHZ
    UDI-DI
    15420045512191
    PMA / PMN Number
    K191281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, UTILIZING THE OMNILOK DEVICE, UPON REMOVING THE DEVICE FROM THE PATIENT THE TIP CAME OFF AND WAS LEFT AT THE END OF THE CERVIX. THE PHYSICIAN REMOVED THE TIP WITH FORCEPS. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454288 CERVICAL SEAL ASSY DEVICE SEAL, CERVICAL, MECHANICAL, UNPOWERED QHZ HOLOGIC, INC OLK-100 15420045512191

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown