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

Model Number LTF-S190-5

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There is no additional information for the event as yet.Event date is not known.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.Upon inspection it was observed that there was a peeling of the objective lens cement.Cause for the peeling could not be established.Incidental observations were the insulation glue of the distal end had a crack, which led to the leak observed by the user.There was also a crack noted on the video connector.

Event Description

As reported for this event, during reprocessing a leak was found in the bending section of the device.There is no patient involvement and no reported harm to any patient or anyone else.

Manufacturer Narrative

Relevant additional information has been received for this event.This information is being provided in this supplemental report.The initial reporter job title is lead spd tech.During reprocessing, after the laparoscopy supracervical hysterectomy procedure was performed and the device was reprocessed.After the device was wiped off, the leak test was performed and the leak was found.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The device history record review confirmed that device was shipped in accordance with specifications.The device was not repaired within past one year.Root cause for the peeling of the objective lens cement cannot be determined.It is likely that it was peeled off by stress from the outside of the endoscope, or the cement was deteriorated by chemical attack from chemical agents, and then, it resulted in peeling off.

• Brand Name: ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
• Type of Device: FLEX DEFLECTABLE VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10593600
• MDR Text Key: 208961156
• Report Number: 8010047-2020-06924
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K080948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2020

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: No Information
• Device Model Number: LTF-S190-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 09/24/2020; 10/27/2020
• Supplement Dates FDA Received: 10/19/2020; 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1