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	07/22/2024
Type of Reportable Event	Malfunction
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 observed during the device inspection, the videoscope generated noise and no image was output due to damage of the imaging unit and board in the video connecter.There were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: h3, h6 and h11.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 15 years since the subject device was manufactured.A definitive root cause was not identified, however based on the results of the investigation, the probable cause of the malfunction would likely be stress of repeated use, external factors, or handling of the device, leading to damage of the image sensor unit or the circuit board of the video connector section, such as disconnection or breakage of components like integrated circuit chips and capacitors, which may have resulted in the malfunction.The event can be prevented by following the instructions for use which state: event, no image showed up: event 1: noise was generated due to breakage of the imaging section, and no image showed up it was confirmed that instructions for hd endoeye laparo-thoraco videoscope ltf-vh chapter 3, ¿preparation and inspection¿ section 3.6, ¿inspection of the endoscopic system¿ describes how to inspect for the subject event.Event 2: noise was generated due to breakage of the circuit board of the video connector section, and no image showed up it was confirmed that instructions for hd endoeye laparo-thoraco videoscope ltf-vh 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.`.

• 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: 19991326
• Report Number: 9610595-2024-16385
• Device Sequence Number: 12876938
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: Other
• Device Model Number: LTF-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2009
• 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