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

Model Number	LTF-VP
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the image of the laparo-thoraco videoscope was fuzzy and one light was out.The issue occurred during a procedure.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the image was foggy.The report is being submitted due to the defect found during evaluation.
Additional Manufacturer Narrative
The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found the scope failed a leak test due to a pinhole in the bending section cover, the bending section cover adhesive was cracked with exposed threads, the objective lens had moisture inside the lens, the light guide lens was cracked, and the video connector had minor cracks.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Although the foggy image was confirmed through evaluation and was likely due to fluid invasion into the objective lens from the leaking area, a definitive root cause of the foggy image could not be determined.The customer may be able to reduce and prevent occurrence of the event by handling device in accordance with the instructions for use (ifu).If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.

• Brand Name: VISERA 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18846509
• Report Number: 9610595-2024-04689
• Device Sequence Number: 12716299
• Product Code: GCJ
• UDI-Device Identifier: 04953170382673
• UDI-Public: 04953170382673
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K955403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2024

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-VP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2006
• 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