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

Model Number LTF-VP

Device Problems Poor Quality Image (1408); Peeled/Delaminated (1454)

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

Event Date 10/05/2021

Event Type  malfunction  

Event Description

The customer reported the laparo-thoraco videoscope had no angulation when the control lever was turned.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the image was foggy and the light guide lens adhesive was peeled off.The report is being submitted due to the defects found during evaluation.

Manufacturer Narrative

During device evaluation at olympus, it was found the video cable of the objective lens was leaking, the bending section cover adhesive was peeled off, the light guide lens adhesive was peeled off and leaking, and angulation was reduced.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The foggy image was likely due to humidity entering the objective lens through a leak due to peeled light guide lens adhesive; however, 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
• 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: 19183378
• MDR Text Key: 341790304
• Report Number: 9610595-2024-08670
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170382673
• UDI-Public: 04953170382673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2024

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: 10/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2010
• 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