MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT OME-V200-U W/POWER CORD; OPERATION MICROSCOPE

Model Number	OME-V200
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A filed service engineer (fse) spoke to an olympus technical assistance center (tac) support.The fse mentioned that the video looked like it was picking up light from a device that was flashing in the room.The fse suggested swapping out the maj-2304 module.The fse confirmed that there was a potential interference issue caused by a third-party navigation system.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported that the image was flashing during an igg usage related to the ome-v200-u w/power cord.There was no image loss however, an observation of a flashing in the upper right corner of the image was seen.The event occurred during procedure and there was no patient harm or user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, the flashing occurred in the image due to a known electromagnetic interference with a third-party navigation system installed in the same room.The following is included in the instructions for use: ¿electromagnetic interference may occur on this instrument near equipment marked with the following symbol or other portable and mobile rf (radio frequency) communications equipment such as cellular phones.If electromagnetic interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument, or shielding the location.¿ olympus will continue to monitor field performance for this device.

• Brand Name: OME-V200-U W/POWER CORD
• Common Device Name: OPERATION MICROSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17287727
• Report Number: 3003637092-2023-00150
• Device Sequence Number: 5510345
• Product Code: IZI
• UDI-Device Identifier: 04953170395871
• UDI-Public: 04953170395871
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K190772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OME-V200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2017
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown