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

Model Number	LTF-S190-10
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed that during the device evaluation, the flex deflectable videoscope exhibited peeling of the adhesive part of objective lens in tip.There were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following field: h3, h6.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, malfunction most likely occurred by physical stress due to bumping or dropping the distal end of the scope, or chemical stress due to the chemical solution used.However, a root cause could not be determined.The events can be detected and prevented in accordance with the following sections of the instructions for use: "operation manual for ltf-s190-10 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 connector, 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 connector, 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 for ltf-s190-10 3.1 compatibility summary methods listed as ¿compatible¿ in table 3.1 and table 3.2 are compatible for routine use only when used according to manufacturers 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¿.3.1 compatibility summary: list of compatible methods validated in terms of biological efficacy and material durability 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 DEFLECTABLE VIDEOSCOPE
• Common Device Name: FLEX 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: 20658360
• Report Number: 9610595-2024-23186
• Device Sequence Number: 8208032
• Product Code: GCJ
• UDI-Device Identifier: 04953170434662
• UDI-Public: 04953170434662
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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
• Operator of Device: Other
• Device Model Number: LTF-S190-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown