BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVICAL SEAL ASSY DEVICE

    MDR report key: 10979042 · Received December 9, 2020

    Report

    Report Number
    1222780-2020-00169
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 18, 2020
    Report Date
    December 9, 2020
    Manufacturer
    HOLOGIC, INC.
    Product Code
    QHZ
    PMA / PMN Number
    K191281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL 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 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 · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, DURING A MYOSURE PROCEDURE, AFTER THE PROCEDURE WAS DONE THE SURGEON REMOVED THE SCOPE, AND THE TIP OF THE OMNI LOK REMAINED IN THE CERVIX OF THE PATIENT. THE PHYSICIAN WAS ABLE TO REMOVE THE TIP WITHOUT ADDITIONAL INTERVENTIONS, AND THERE WERE NO CONSEQUENCES TO THE PATIENT. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442857 CERVICAL SEAL ASSY DEVICE SEAL, CERVICAL, MECHANICAL, UNPOWERED QHZ HOLOGIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1