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

Model Number LTF-190-10-3D

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

A device evaluation confirmed the customer allegation.Defect in the universal cord was noted.Air/water leakage was noted from the insertion tube and universal cord due to cut or scratch on the bending section and universal cord.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is available.

Event Description

The customer reported to olympus, the videoscope exhibited air/water leakage or fluid invasion.The issue was observed after use and not during procedure.The device was returned and an evaluation revealed, the adhesive on the videoscope tip was damaged.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no patient involvement.

Manufacturer Narrative

This report is being submitted for information regarding device return date and additional inspection findings.There were few additional inspection findings.The charge coupled device (ccd) unit cover lens glue was cracked.The adhesive of the bending section cover was separated.The cable tube unit had buckles.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if additional information is available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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, the root cause of the damage to the adhesive on the videoscope tip was chemical/physical stress to the device.The event can be prevented by following the instructions for use which state: ¿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.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®.

• 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: 15824126
• MDR Text Key: 307560398
• Report Number: 9610595-2022-04208
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170340710
• UDI-Public: 04953170340710
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K123365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 12/14/2022; 02/21/2023
• Supplement Dates FDA Received: 12/14/2022; 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2013
• 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