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

Model Number LTF-S190-10

Device Problems Degraded (1153); Mechanical Problem (1384); Peeled/Delaminated (1454)

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

Event Type  malfunction  

Event Description

Company representative sent a repair request reported with an issue of " looseness/rattling of the connector".No harm was reported.No patient harm, no user injury reported.Device evaluation, the adhesive around objective lens found to be peeled off.This report is being submitted due to the finding of adhesive around objective lens peeled off (deterioration, physical stress) identified during device return evaluation.

Manufacturer Narrative

E1- address: full name of the establishment is (b)(6) hospital.The subject device was received and evaluated.Device evaluation found the light guide (lg) connector cover glass was loose and the venting connector of lg connector noted loose.The reported issue of '"looseness/rattling of the connector" was confirmed.Furthermore, as stated in section b5, adhesive around objective lens found to be peeled off.This condition was attributed due to deterioration, breakage of the adhesive caused by chemical/physical stress during use/cleaning.Additionally, the following defects were identified during device inspection: adhesive on a-rubber (adhesive connection) has a chip.A-rubber has a scratch.Protector of universal cord on s-connector side has a scratch.Video connector found deformed.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

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 objective lens adhesive peeling issue could not be determined, however, the issue was likely the result of repetitive use stress, external factors, or user handling.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 (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: 16791597
• MDR Text Key: 313843980
• Report Number: 9610595-2023-06515
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• 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: 03/29/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2019
• 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