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

Model Number LTF-VP

Device Problem Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The customer's allegation was confirmed.The device evaluation found the foggy image was due to leakage from the objective lens.A review of the device history record found no deviations that could have caused or contributed to the reported issue.A definitive root cause of the image center clouding could not be identified.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, this report will be supplemented.Olympus will continue to monitor the field performance of this device.

Event Description

It was reported, the videoscope image was cloudy.It is unknown when the issue occurred.There were no reports of patient harm.

• Brand Name: VISERA LAPARO-THORACO VIDEOSCOPE
• Type of Device: 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: 19093914
• MDR Text Key: 340002859
• Report Number: 9610595-2024-07701
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2024

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
• Device Operator: Health Professional
• Device Model Number: LTF-VP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1