MAUDE Adverse Event Report: OD-OS GMBH NAVILAS LASER SYSTEM 577S; POWERED LASER SURGICAL INSTRUMENT

Model Number	NAVILAS® LASER SYSTEM 577S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Retinal Injury (2048)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No malfunction is evident at this stage.The possible causes of this event were: user error (ignoring aiming beam warnings and ifu), labeling, or usability issues.Nonetheless, evaluation of labelling and information provided by the manufacturer (both on ifu and graphic user interface) was adequate.The user elected to proceed with the laser treatment despite the warning message.Thus, no field safety corrective action is necessary.The service installation records were reviewed for this laser system and there were no problems related to the scanner calibration or aiming beam.The system log files were analyzed and the records confirmed that the user ignored and overrode the error messages warning that the aiming beam was not visible.However, as the investigation is still ongoing.The optical head will be sent to the od-os facility for testing to determine whether any malfunction may have occurred.Manufacturer reference #: (b)(4).
Event or Problem Description
On (b)(6) 2026, the customer reported hearing a strange "static noise" coming from the laser optical head of a navilas 577s laser system device (sn (b)(6)) lasting approximately 5 minutes before disappearing.Subsequently, the customer performed a treatment session, and upon review of the treatment documentation, the physician observed the laser firing within the set exclusion boundary rather than the intended treatment zone.The system's log files from the date of the incident showed multiple warnings related to the aiming beam position not being verified, including: · "aiming beam position could not be verified.Improve aiming beam visibility." "system is unable to confirm aiming beam position." · "rejected spot application due to missing aiming beam position." the user elected to proceed with the laser treatment despite the warning messages.The treatment images later showed spot offset in two treatment patterns, including some spots within the exclusion area.No burns were visible in the central macula, and the fovea was not affected.The physician reported that no significant vision loss was observed nor is expected, and the patient's prognosis is good.Service inspections were performed on (b)(6) 2026, and it was confirmed that: calibration of the optical head was within specification.· aiming beam alignment was correct.No abnormal noise could be reproduced.The system functioned normally during simulated treatments.At this stage, no device malfunction has been identified.Device warnings and safety messages operated as designed.The investigation is ongoing, and the optical head will undergo further testing at the manufacturer's facility.

• Brand Name: NAVILAS LASER SYSTEM 577S
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): OD-OS GMBH; warthestrasse 21; teltow, brandenburg 14513 ; GM 14513
• Manufacturer (Section G): OD-OS GMBH; warthestrasse 21; teltow, brandenburg 14513 ; GM 14513
• Manufacturer Contact: camila ilgenfritz ; warthestrasse 21; teltow, brandenburg 14513 ; GM 14513
• MDR Report Key: 24754074
• Report Number: 3008252121-2026-00001
• Device Sequence Number: 21161870
• Product Code: GEX
• UDI-Device Identifier: 04260284390013
• UDI-Public: 04260284390013
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K162191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NAVILAS® LASER SYSTEM 577S
• Device Catalogue Number: 156000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 77 YR
• Patient Sex: Male