MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

Model Number LTF-190-10-3D

Device Problem Leak/Splash (1354)

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

Event Date 01/30/2024

Event Type  malfunction  

Event Description

It was reported, the flex 3d deflectable videoscope had a leak in the tip.The issue occurred during reprocessing.There were no reports of patient harm.

Manufacturer Narrative

The device was returned, and the evaluation found that the adhesive deterioration of the objective lenses was very likely the result of a phenomenon that has occurred throughout reprocessing.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to d4.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, it is likely that the event occurred due to physical stress caused by hitting the tip of the scope or dropping the tip, or chemical stress due to the chemical solution used, but it cannot be identified.The adhesive deterioration of the objective lenses is very likely the result of a phenomenon that has occurred throughout reprocessing.It is possible that the device has been exposed to heat, which can explain such signs of degradation.The event can be detected/prevented by following the instructions for use which state: ltf-190-10-3d operation manual important information ¿ please read before use: contraindications, warnings, and precautions: do not strike, hit, or drop the endoscope¿s distal end, rigid portion, bending section, control section, universal cord, video connectors, or light guide connector.Also, do not bend, pull, or twist the endoscope¿s distal end, rigid portion, bending section, control section, universal cord, video connectors, or light guide connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.Ltf-190-10-3d reprocessing manual 3.1 compatibility summary: methods listed as ¿compatible¿ in table 3.1 and 3.2 are compatible for routine use only when used according to manufacturer¿s instructions.Repeated use and reprocessing of endoscopes and accessories lead to gradual wear and tear.Furthermore, reprocessing methods that employ higher temperatures and more caustic/corrosive materials may lead to faster deterioration.In general, sterilization processes are harsher on equipment than disinfection processes.Before each patient procedure, inspect the endoscope and accessories for damage, according to the instructions described in this manual and its companion ¿operation manual¿.Reprocessing manual: 3.1 compatibility summary: list of compatible methods validated in terms of material durability: sterrad® 50/100s/200/nx¿: sterilization by sterrad® 50/100s/200/nx¿ system may deteriorate the adhesive of the insertion section.Depending on the circumstances, replacement of the insertion section may be required.Before use, confirm that the endoscope is free from any damage or other irregularities.For further details, contact olympus.Olympus will continue to monitor field performance for this device.

• Brand Name: ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
• Type of Device: FLEX 3D 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: 18753832
• MDR Text Key: 336201880
• Report Number: 9610595-2024-03686
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170434938
• UDI-Public: 04953170434938
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K123365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

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-190-10-3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2015
• 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