MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS PLEURA VIDEOSCOPE; FLEX DEFLECTABLE VIDEOSCOPE

Model Number LTF-240

Device Problem Component Missing (2306)

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

Event Date 08/21/2023

Event Type  malfunction  

Event Description

It was reported to olympus, that the evis pleura videoscope was leaking.The issue was found during reprocessing after a procedure and the procedure was completed with another device.Inspection and testing of the returned device found that the objective lens was missing.There were no reports of patient harm associated with this event.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

The device was returned for evaluation and the customers allegation was not confirmed.It was noted that the image was blurry and the angle knob was damaged.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

Updated: h6, h10.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, a definitive root cause of the observed detached objective lens issue could not be determined, however, the issue was likely the result of physical stress, user handling/mishandling.The event may be detected/prevented by following the instructions for use sections below: operation manual: important information ¿ please read before use: danger, warnings and cautions.Operation manual: 3.2 preparation and inspection of the endoscope.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS PLEURA VIDEOSCOPE
• Type of Device: FLEX DEFLECTABLE 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: 17773614
• MDR Text Key: 323728431
• Report Number: 9610595-2023-13611
• Device Sequence Number: 1
• Product Code: EWY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

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-240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2011
• 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