MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

Model Number LTF-S190-5

Device Problem Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Event Description

The customer reported to olympus the endoeye flex deflectable videoscope had image noise.The procedure was a therapeutic laparoscopy.There were no reports of patient or user harm associated with this event.Inspection and testing of the returned device found that the image disappears at angle.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the following: image noise; the curved rubber had scratches; objective lens had scratches; image disappears at the angle; the curved rubber adhesive is missing; and the right/left lever does not operate smoothly.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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, the root cause of the no image was a short-circuit of the image sensor cable.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 9610595.

• Brand Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
• Type of Device: FLEX DEFLECTABLE VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; odakura, nishigo-mura; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; odakura, nishigo-mura; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17315730
• MDR Text Key: 319722080
• Report Number: 3002808148-2023-07056
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170310355
• UDI-Public: 04953170310355
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2024

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-S190-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 07/21/2023; 05/15/2024
• Supplement Dates FDA Received: 08/07/2023; 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2019
• 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