BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPMI PENTERO

    MDR report key: 9571284 · Received January 9, 2020

    Report

    Report Number
    9615010-2020-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2020
    Date of Event
    November 1, 2019
    Report Date
    December 12, 2019
    Manufacturer
    CARL ZEISS MEDITEC AG (OBERKOCHEN)
    Product Code
    FSO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CZMI BECAME AWARE OF THE EVENT THROUGH A MANDATORY AND VOLUNTARY REPORT FORM (#(B)(4)) SUBMITTED BY THE SITE'S PATIENT SAFETY COORDINATOR. CZMI MADE FOUR ATTEMPTS TO GATHER ADDITIONAL DETAILS REGARDING THE PATIENT OUTCOME FROM THE PATIENT SAFETY COORDINATOR. A RESPONSE TO THE INQUIRIES HAS NOT BEEN RECEIVED. A REQUEST FOR A DEVICE INSPECTION WAS ALSO DECLINED BY THE SITE'S BIOMEDICAL ENGINEER.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL (HCP) SUBMITTED A MANDATORY AND VOLUNTARY REPORT FORM (# (B)(4)) TO THE FDA. ACCORDING TO THE REPORT, DURING A PROCEDURE IN THE OPERATING ROOM IT WAS NOTED THAT THE VIEW THROUGH THE MICROSCOPE WAS VIBRATING UNCONTROLLABLY. ALSO ACCORDING TO THE REPORT, THE SURGEON EXPERIENCED HEADACHES AND NAUSEA DUE TO THE INSTABILITY OF THE MICROSCOPE VIEW AND DECIDED TO ABORT THE CASE DUE TO SAFETY CONCERNS FOR THE PATIENT. THE FINAL OUTCOME OF THE PATIENT IS NOT KNOWN TO CARL ZEISS MEDITEC, INC.(CZMI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30628 OPMI PENTERO MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY FSO CARL ZEISS MEDITEC AG (OBERKOCHEN) N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1