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 image of the endoeye flex deflectable videoscope had static.The issue was found during preparation for use, and the procedure was completed using a similar device.There were no reports of patient harm.

Manufacturer Narrative

E1 establishment name: (b)(6) hospital.The device was returned and evaluated, and the customer¿s allegation of image was static was not confirmed.Device evaluation found that due to damage on charged coupled device unit, image noise occurred and temporarily the image could not be seen, due to deformation of video connector and case, water tightness was lost, due to damage on insertion pipe, insulation resistance value did not meet the standard value, adhesive on bending rubber section had a chip, due to deformation of bending tube, bending angle in down direction exceeded the standard value, due to damage on the forceps elevator lever, the bending section could not be fixed firmly, due to damage on charged coupled device unit, and a noisy image occurred during angulation in up and down directions.A review of the device history record found no deviations that could have caused or contributed to the reported issue.There was no indication that the event was caused by a misuse or that the event was related to design of the device.Repair history was reviewed and no issues were found related to the reported event.The device was noted to be previously repaired in november 2022.Although a definitive root cause of the defect could not be identified, it was determined that the defect was likely caused due to breakage of the image sensor unit including disconnection by stress of repeated use, external factors or handling, or that the components of the integrated circuit chip and capacitor mounted on the electric circuit board had a defect.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: 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 (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: 17815923
• MDR Text Key: 324227324
• Report Number: 9610595-2023-14033
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170434648
• UDI-Public: 04953170434648
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/26/2023

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-S190-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2017
• 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