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

Model Number LTF-S190-10

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304); Electrical Shorting (2926)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event/event: no additional information was available.The device was evaluated by olympus, and the reported issue was confirmed.Two (2) additional reportable malfunctions were identified.An e216 (scope communication error) occurred due to a short-circuit of the image sensor cable.Additional issues were identified.White scratches were visible on the image.The bending section cover adhesive was missing.The light guide connector was deformed due to external factors.The video connector case was cracked due to external factors.Scratches were found in multiple locations on the device.The investigation was ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The olympus representative reported the endoeye flex deflectable videoscope presented a connection error (no image-unrestorable-error code) when angling.No patient injury or procedure impact reported.

Manufacturer Narrative

Correction: h4 - feb 15, 2015 should have been selected on the initial report rather than feb 16, 2015.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, the root cause of the event was unable to be identified; however, the event most likely occurred due to the ccd cable becoming disconnected, the ccd being damaged, or the board inside the connector is malfunctioning.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOEYE FLEX DEFLECTABLE 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15487978
• MDR Text Key: 306333068
• Report Number: 9610595-2022-02257
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170310386
• UDI-Public: 04953170310386
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTF-S190-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2015
• 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