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

Model Number LTF-190-10-3D

Device Problem Corroded (1131)

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

Event Type  malfunction  

Manufacturer Narrative

During inspection and testing, the adhesive on the objective lens was deteriorated.A review of the device history record found no deviations that could have caused or contributed to the deterioration of the adhesive.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the adhesive deteriorated due to physical stress and/or chemical stress due to sterilization with chemicals and/or sterrad system.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warning, which may help to prevent the issue: "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." the device's reprocessing manual states the following: compatibility summary: methods listed as ¿compatible¿ 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¿."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.In addition, the bending section cover was pierced and leaky and the master and slave plug units were cracked.Per the legal manufacturer, these device defects have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.

Event Description

The loaner device was sent to an olympus service center for asset inspection.During inspection and testing, the adhesive on the objective lens was deteriorated.There was no harm or user injury reported due to the event.

• 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15703578
• MDR Text Key: 307087608
• Report Number: 9610595-2022-03519
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170340710
• UDI-Public: 04953170340710
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K123365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• 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: 08/19/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2016
• 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