MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. HD ENDOEYE LAPARO-THORACO VIDEOSCOPE

Model Number	LTF-VH
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue was identified.Based on the results of the investigation, it is likely the event occurred due to the following factors: the video connector board had not been repaired or replaced since december 2010 (approximately 13 years and 6 months), and the image output signal temporarily became unstable due to deterioration over time.Dust, stain, or foreign material adhered to the electrical contacts of the scope connector, and the connection state was not sufficient, which temporarily affected the electrical connection with the system.Scratches and chips were found on the adhesive of the bending section, and it was confirmed that the internal electrical circuit of the image sensor in the image sensor unit built into the distal end of the scope was hit, dropped, etc.Mechanical stress (load) was applied to the electrical connection, which temporarily deteriorated the electrical connection.That had a negative effect on the image signal output and made the image signal output unstable.Electrical load (stress) caused by current flow to the image sensor mounted on the image sensor unit built into the tip of the scope and the electrical board inside the scope connector (including the electrical components mounted on the electrical board), accidental application of static electricity, overcurrent caused by connecting/disconnecting while the system is on, etc.Temporarily deteriorates the electrical connection, adversely affecting the image signal output and making it unstable.The event can be prevented by performing pre-use and periodic inspections.The device is out of warranty and in consideration for repair or replacement.The root cause of the reported issue could not be identified.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the laparo-thoraco videoscope had no image.The procedure was therapeutic, also, the intended procedure was completed using similar.There were no reports of patient harm.

• Brand Name: HD ENDOEYE LAPARO-THORACO VIDEOSCOPE
• Common Device Name: LAPARO-THORACO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19528770
• Report Number: 9610595-2024-11931
• Device Sequence Number: 18044006
• Product Code: GCJ
• UDI-Device Identifier: 04953170287015
• UDI-Public: 04953170287015
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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: LTF-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2010
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OTV-S190-VISERA ELITE VIDEO SYSTEM CENTER
• Patient Sex: Unknown