BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVICAL SEAL ASSY DEVICE

    MDR report key: 11281217 · Received February 4, 2021

    Report

    Report Number
    1222780-2021-00020
    Event Type
    Malfunction
    Date Received
    February 4, 2021
    Date of Event
    December 16, 2020
    Report Date
    February 4, 2021
    Manufacturer
    HOLOGIC, INC.
    Product Code
    QHZ
    UDI-DI
    15420045512191
    PMA / PMN Number
    K191281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED IDENTIFICATION NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON DECEMBER 16TH, WHILE USING A OMNILOK IN A PATIENT, THE TIP OF THE DEVICE CAME OFF THE END AND THE PIECE DISPERSED IN THE THEATRE ROOM. NO IMPACT TO PATIENT OR USER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180056 CERVICAL SEAL ASSY DEVICE SEAL, CERVICAL, MECHANICAL, UNPOWERED QHZ HOLOGIC, INC. OLK-100 19L29RF 15420045512191

    Patients

    Seq Age Sex Outcome Treatment
    1 Other