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

Model Number LTF-190-10-3D

Device Problems Fluid/Blood Leak (1250); Poor Quality Image (1408); Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to the service center for evaluation.The customer¿s complaint was not confirmed.A visual inspection found the bending section glue was found peeling off.The master objective lens glue was noted to be peeled off causing the lens to fail the fog test.The scope prong was found bent.The scope passed the leak test.The instruction manual states, ¿if the endoscope is dropped or the distal end of the endoscope receives a hard impact, the endoscope may be damaged even if a crack or chip of the lens on the distal end cannot be found.In this case, stop using the endoscope and contact olympus.¿.

Event Description

The service center was informed that during reprocessing the user facility noted fluid invasion on the scope.The user facility reported that there were no visual abnormalities observed.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Please see the updates in sections: g4, g7, h2 and h10.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm confirmed that the subject device was not repaired in past one year.The lm also, reported that from the complaint information, cause or root cause was not able to be identified.Because peeling off of the bonding part of the a rubber was confirmed, it was assumed that the adhesive agent might have been peeled off by impact from the outside to the distal end, or the adhesive agent might have been deteriorated by chemical attack from chemical agents used during reprocessing.

• 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: 10292194
• MDR Text Key: 208104560
• Report Number: 8010047-2020-04540
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170434938
• UDI-Public: 04953170434938
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• 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: 06/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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