BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPMI PENTERO

    MDR report key: 2020316 · Received March 11, 2011

    Report

    Report Number
    9615010-2011-00004
    Event Type
    Other
    Date Received
    March 11, 2011
    Date of Event
    February 9, 2011
    Report Date
    March 11, 2011
    Manufacturer
    CARL ZEISS SURGICAL GMBH
    Product Code
    EPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM AND MICROSCOPE WERE INSPECTED BY A SERVICE TECHNICIAN ON THE DATE OF EVENT ((B)(6) 2011). THE TECHNICIAN FOUND FUNCTIONS WORKING WITHIN SPECIFIED LIMITS AND DID NOT DETECT ANY MALFUNCTION OF THE DEVICE. ADDITIONAL TRAINING TO THE CUSTOMER WAS PROVIDED. THE CUSTOMER IN THE ENT DEPARTMENT WILL FOLLOW THE SAFETY INSTRUCTIONS DESCRIBED IN THE USER MANUAL. THE PRODUCT LABELING PROVIDES INFO REGARDING PHOTOTOXIC TISSUE INJURY RECOMMENDING, AMONG OTHER THINGS, USE OF THE LOWEST LIGHT SETTING POSSIBLE, REDUCING THE EXPOSURE TIME TO A MINIMUM AND TAKING PRECAUTIONS TO IRRIGATE THE SURGICAL FIELD.

    Description of Event or Problem · 1

    A SITE REPORTED THAT A PT RECEIVED A SECOND DEGREE BURN DURING AN ENT PROCEDURE. PT WAS UNDER ANESTHESIA. THE OPMI PENTERO SURGICAL MICROSCOPE HAD BEEN TRANSFERRED FROM THE NEUROSURGERY DEPT TO THE ENT DEPARTMENT. THE DOCTOR WAS NOT TRAINED ON THE OPMI PENTERO OR IN REGARDS TO LIGHT HAZARDS FROM HIGH ILLUMINATION LIGHT SOURCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPMI PENTERO SURGICAL MICROSCOPE EPT CARL ZEISS SURGICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other