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

Model Number LTF-190-10-3D

Device Problem Component Missing (2306)

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

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found deterioration of the objective lenses gluing with missing parts due to user mishandling.Additional findings include the following: the bending section cover was pierced and leaky, the grip cover had a pin deformation causing an abnormal feeling of switch operation, the light guide mount ring painting had partially melted, the scope connector cover had slight wear and tear.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, the endoeye flex 3d deflectable videoscope had leaky optics when performing a leak test.The issue was found during preparation for use.Inspection and testing of the returned device found deterioration of the objective lenses gluing with missing parts.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

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 cracking and peeling of adhesive on the tip (objective lens, lighting lens) could not be determined, however, it is possible the issue was the result of physical stress caused by hitting the tip of the scope, dropping the tip, etc., or chemical stress due to the chemicals used, etc.The event may be detected/prevented by following the instructions for use sections below: ¿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: 16710227
• MDR Text Key: 313013264
• Report Number: 9610595-2023-05903
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170340710
• UDI-Public: 04953170340710
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K123365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/13/2023

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-190-10-3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/10/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 05/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2015
• 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