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

Model Number	LTF-VH
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 establishment name: (b)(6).The evaluation of the event 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 an image defect with horizontal lines all over the screen.The issue occurred during preparation for use.The doctor replaced it with another similar device and completed the procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it was presumed that the suggested event may have occurred broken image sensor or the electronic parts on the circuit board in the video connector such as a capacitor and no irregularities were found for the image sensor cable.However, the definitive root cause of the event was unable to be specified since the causal investigation for the electronic parts was very difficult to conduct.Thus, the device did not meet its functions and specifications, thereby confirming the occurrence of the event.The event can be detected/prevented by following the instructions for use: it was confirmed that instructions operation manual chapter 3, ¿preparation and inspection¿ section 3.6, ¿inspection of the endoscopic system¿ describes how to inspect for the subject event.Olympus will continue to monitor field performance for this device.Additional information: b5, d8, d9, h3.
Event or Problem Description
Additional information: the issue occurred during preparation for use for a therapeutic laparoscopic cholecystectomy procedure.

• 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: 20043284
• Report Number: 9610595-2024-16842
• Device Sequence Number: 7977158
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2011
• 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 (VIDEO SYSTEM CENTER) SN: (B)(6).
• Patient Sex: Unknown