BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVICAL SEAL ASSY DEVICE

    MDR report key: 13282814 · Received January 18, 2022

    Report

    Report Number
    1222780-2022-00023
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Date of Event
    January 6, 2022
    Report Date
    January 18, 2022
    Manufacturer
    HOLOGIC, INC.
    Product Code
    QHZ
    UDI-DI
    15420045512191
    PMA / PMN Number
    K191281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT/SERIAL NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. WE ARE CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. 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 AND A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. 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 ON AN UNKNOWN DATE, DURING A OMNI LOK PROCEDURE, THE TIP OF THE DEVICE DISCONNECTED AND FELL INTO THE PATIENT´S CAVITY, IT WAS RECOVERED USING TWEEZERS AND NO PATIENT INJURY WAS REPORTED. THE PROCEDURE WAS COMPLETED AND THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820884 CERVICAL SEAL ASSY DEVICE SEAL, CERVICAL, MECHANICAL, UNPOWERED QHZ HOLOGIC, INC. OLK-100 21A26RV 15420045512191

    Patients

    Seq Age Sex Outcome Treatment
    1 Female