BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S88 / OPMI LUMERA T

    MDR report key: 20995315 · Received December 20, 2024

    Report

    Report Number
    9615010-2024-00011
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    December 4, 2024
    Report Date
    March 7, 2025
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA) OKO
    Product Code
    FSO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIPTION OF CHANGES: FIELD B4: ADDED "DATE OF THIS REPORT" 03/07/2025. FIELD G3: UPDATED "DATE RECEIVED BY MANUFACTURER" TO "03/05/2025". FIELD G6: CHECKED "30 DAYS", UPDATED TO "FOLLOW-UP, # 1". FIELD H2: CHECKED "DEVICE EVALUATION." FIELD H3: UPDATED "DEVICE EVALUATED BY MANUFACTURER?" TO "YES". FIELD H6: ADDED "TYPE OF INVESTIGATION" CODE 10, ADDED "INVESTIGATION FINDINGS" CODE 213, ADDED " INVESTIGATION CONCLUSION" CODE 67, AND CODE 4315. FIELD H11: ADDED DESCRIPTION OF CHANGES. FILE ATTACHMENTS: ATTACHED DEVICE EVALUATION.

    Additional Manufacturer Narrative · 0

    FINAL ROOT CAUSE ANALYSIS WILL BE PERFORMED UPON MANUFACTURER INVESTIGATION OF THE RETURNED PARTS.

    Description of Event or Problem · 0

    A CUSTOMER FROM SPAIN REPORTED THAT THE MICROSCOPE HEAD BROKE OFF FROM THE MICROSCOPE ARM WHILE A PATIENT WAS UNDER IT. THE DOCTOR CAUGHT THE MICROSCOPE HEAD BEFORE IT COULD HIT THE PATIENT. ISSUE OCCURRED DURING PREPARATION FOR SURGERY. THE PROCEDURE WAS CANCELED. THERE WAS NO INJURY TO ANYONE PRESENT AT THE TIME OF THE INCIDENT. NO AFTER-TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2355790 S88 / OPMI LUMERA T OPMI LUMERA T FSO CARL ZEISS MEDITEC AG (JENA) OKO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown