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

Model Number	LTF-190-10-3D
Medical Device Problem Codes	No Display/Image (1183); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the device evaluation, the endoeye flex 3d deflectable videoscope had no image, the adhesive on the objective lens had peeled off.There were no reports of patient involvement.
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, that the deflectable videoscope had no image due to damage on the charged coupled device unit, no image due to electrical contact of the video connector being shaved, and the objective lens adhesive was peeled off.There were no reports of patient involvement.
Additional 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, for the first reportable malfunction of no image, olympus presumes that the image sensor unit, inner circuit board, and electrical contacts may have had anomalies, which lead to no image.One probable cause is external stress to the insertion section, as chipping was observed on the glue of the bending section cover.Another probable cause is irregular load to the inner circuit board, which resulted in anomaly of the electrical contacts as multiple damaged sites were observed on the video connector.For the second reportable malfunction of adhesive peeling, olympus determined the cause was unable to be specified.Olympus presumes that physical stress of bumping the distal end, dropping the distal end, or chemical stress of chemical solutions in use may have caused it.However, a definitive root cause for both malfunctions cannot be determined.The 1st event can be prevented by following the instructions for use which state: instructions for ltf-190-10-3d operation manual chapter 3, ¿preparation and inspection¿ section 3.6, ¿inspection of the endoscopic system¿ ¿¦inspection of the endoscopic image¿ the 2nd event can be prevented by following the instructions for use which state: instructions for 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.Instructions for ltf-190-10-3d reprocessing manual chapter 3, ¿compatible reprocessing methods and chemical agents¿ section 3.1 ¿compatibility summary¿ precaution 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¿.Section 3.1, ¿compatibility summary¿ ¿¿ sterrad® 50/100s/200/nxtm¿ list of compatible methods validated in terms of 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 3D DEFLECTABLE VIDEOSCOPE
• Common Device Name: 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: 20355938
• Report Number: 9610595-2024-19937
• Device Sequence Number: 17944226
• Product Code: GCJ
• UDI-Device Identifier: 04953170434938
• UDI-Public: 04953170434938
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123365
• 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): 10/21/2024

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-190-10-3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2016
• 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