MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

Model Number LTF-190-10-3D

Device Problems Peeled/Delaminated (1454); Component Missing (2306)

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

Event Type  malfunction  

Event Description

As reported, during cleaning that there was a leakage during leak test.The view was not optimal.Customer also reported that no harm or injury (included infection) was caused to patient.Device return evaluation found the gluing appearance of the objective lenses showed a deterioration with cracking and visible missing parts.This report is being submitted due to gluing appearance of the objective lenses showed deterioration with crack and missing parts.

Manufacturer Narrative

Device inspection found the customer reported issue was confirmed.During the image inspection process, it was identified that it was impossible to see in 3d properly.The issue involved was a visual discomfort due to depth-of-field in conflict with convergence causing a faulty 3d image.A complementary test was successfully carried out to adjust properly the image centering.The check of the gluing appearance of the objective lenses showed a deterioration with cracking and visible missing parts.The air leak test revealed a deep perforation by cutting of the a-rubber, but without metal exposure.Waterproof tape was wrapped around the sheath and one additional leak was discovered in the area of the universal cord.The instrument was being partially disassembled.No humidity was found out inside the device.Technical evaluation and a further inspection have highlighted the customer claim related to a 3d image issue whose operational functionality was no longer found to be defective after adjusting the image centering.Furthermore, the causal link between both a-rubber and the universal cord unit damage was probably the use of a pointed or sharp object that has been in contact with the said parts and caused two major leakages.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.It has been over 7 years since the subject device was manufactured.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 legal manufacturer's investigation, the deterioration of the objective lenses gluing appearance (showed by loupe a noticeable crumbling with missing parts) is very likely the result of a phenomenon that has likely occurred throughout reprocessing.It was likely due to external stress to the distal end or chemical attack from chemical agents or the like.The instruction manual identifies the following related verbiage: ¿operation manual: important information ¿ please read before use: dangers, warnings, and cautions: 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.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¿.¿ 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): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13311158
• MDR Text Key: 295347706
• Report Number: 8010047-2022-01746
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170340710
• UDI-Public: 04953170340710
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 02/28/2022

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: 12/23/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2021
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2013
• 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