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

Model Number LTF-S190-5

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 08/01/2022

Event Type  malfunction  

Event Description

The olympus representative reported the angulation on the endoeye flex deflectable videoscope stayed angled even when unlocked.No patient injury or procedure impact reported.

Manufacturer Narrative

Additional information was requested from the reporter.A supplemental report will be submitted should additional information be made available.The device was returned to olympus for evaluation and the reported issue was confirmed.The operating part was caught during angle operation.The bending section was crushed due to external factors.The bending angle was insufficient due to the elongation of the angle wire.The bending section cover adhesive was missing.Scratches were found in multiple locations on the device.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the customer and the legal manufacturer¿s investigation.Device history records: the device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Complaint history review: no similar complaints were confirmed for the angle lock for the model or from the product group.Conclusion: the root cause could not be identified.The issue was likely to have been caused by a catch when the angle knob was activated.The catch occurs when the angle knob is operated.The angle was locked and could not be unlocked.Although the cause cannot be specified, the angle wire could not move smoothly due to the collapsed bending part that may have been a factor in the problem.The collapse of the curvature is likely to have been caused by external factors.The device angulation was not locked and there was a catch when the angulation control knob was operated, but it worked.Olympus will continue to monitor the field performance of this device.

Event Description

The issue happened during a therapeutic unknown procedure.The procedure was completed using a similar 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: 15326467
• MDR Text Key: 305378036
• Report Number: 9610595-2022-01469
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• 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: 08/08/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2021
• 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