BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILAS LASER SYSTEM

    MDR report key: 7107066 · Received December 11, 2017

    Report

    Report Number
    3008252121-2017-00002
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 11, 2017
    Report Date
    January 23, 2018
    Manufacturer
    OD-OS GMBH
    Product Code
    GEX
    PMA / PMN Number
    K162191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL INVESTIGATION (BASED ON FIELD INVESTIGATION OF THE LASER SYSTEM AND REVIEW OF MANUFACTURING DEVICE HISTORY RECORDS) REVEALED THAT THE ROOT CAUSE FOR TREATMENT OF THE UNINTENDED AREA WAS A FOUND TO BE AN INVALID CALIBRATION OF THE DEVICE BY THE SERVICE TECHNICIAN. THE DEVICE IS BEING RETURNED TO OD-OS AND THE FINAL INVESTIGATION FINDINGS WILL BE REPORTED IN A FOLLOW-UP REPORT. VITREOUS HEMORRHAGE IS A KNOWN RISK OF THE PROCEDURE AND OFTEN ACCOMPANIES RETINAL TEARS, WHICH WAS THE PATIENT'S UNDERLYING CONDITION AND REASON FOR TREATMENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE NAVILAS LASER SYSTEM WAS RETURNED TO OD-OS (B)(4), CLEANED, DECONTAMINATED, AND EVALUATED. THE FINAL INVESTIGATION CORROBORATED THE RESULTS FROM THE INITIAL INVESTIGATION WHERE THE INVALID CALIBRATION WAS REPRODUCED, MEASURED, AND CONFIRMED. THE ACTUAL LASER MISPLACEMENT WAS EQUIVALENT TO THE THEORETICAL CALCULATION. IN ADDITION, THE OPTICAL HEAD WAS SUBJECTED TO COMPREHENSIVE TESTING AND NO MECHANICAL FAULTS WERE IDENTIFIED. THE SYSTEM WAS REPAIRED AND RECALIBRATED AND PASSED FINAL INSPECTION TESTING. IN CONCLUSION, THE DEVICE MALFUNCTION WAS CONFIRMED TO BE SOLELY ATTRIBUTED TO INVALID CALIBRATION PERFORMED BY FOREIGN SERVICE PERSONNEL. MANUFACTURER'S COMPLAINT #: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017 A PATIENT WITH PREEXISTING PERIPHERAL RETINAL TEARS UNDERWENT ATTEMPTED LASER PHOTOCOAGULATION IN THE RIGHT EYE. THE TREATMENT WAS BEING PERFORMED IN ORDER TO PREVENT RETINAL DETACHMENT. DURING THE PROCEDURE, THE SURGEON REPORTS THAT THE TREATMENT WAS NOT DELIVERED TO THE TARGET AREA, SO HE INCREASED THE LASER ENERGY AND TREATED THE PATIENT A SECOND TIME. AFTERWARDS THE SURGEON REPORTS THAT A VITREOUS HEMORRHAGE OCCURRED AND THE LASER TREATMENT WAS DELIVERED POSTERIOR TO THE TARGET AREA, THEREFORE LEADING TO PHOTOCOAGULATION OF TISSUE NOT INTENDED TO BE TREATED IN THE PERIPHERAL RETINA. THE RETINAL IMAGE WAS REVIEWED BY THE OD-OS MEDICAL MONITOR (RETINA SPECIALIST) WHO GRADED THE VITREOUS HEMORRHAGE AS 1+ AND CONFIRMED THE TREATMENT AREA REMAINED WITHIN THE PERIPHERAL RETINA AND THERE WAS NO EVIDENCE OF DAMAGE TO THE MACULA OR FOVEA. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE SURGEON. AT THIS TIME, THERE IS NO REPORT OF INTERVENTION OR ADVERSE IMPACT ON VISION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED BY THE RETINA SPECIALIST, WHO REPORTS THAT THE DEVICE MALFUNCTION HAD NO ADVERSE EFFECT ON THE PATIENT'S HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886044 NAVILAS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX OD-OS GMBH 577S

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR