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

Model Number LTF-S190-5

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There is no additional information available for this event as yet.Event date is not known.The device is returned but the device evaluation is not yet completed.As such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

Event Description

As reported for this event, during set up the device experienced a loss of image.There is no patient involvement and no harm or adverse impact reported to patient or anyone.

Manufacturer Narrative

The device evaluation is now completed.This supplemental report is being submitted to provide this information.Please see the updates in sections: g4, g7, h2, h3, h4, h6, and h10.The device history record review confirmed that device was shipped in accordance with specifications.Repair history of within past one year was reviewed, and it was confirmed that the device distal end bending section was repaired in (b)(6) 2020.Reported for the device was a loss of image.Upon inspection and testing, unable to duplicate the user reported issue of loss of image.The device has a good image.It was plugged onto the processor for about 1 hour without any image problem, image remained good after cables and bending section manipulation.Additionally, a leak on the distal end rubber insulation (a-rubber) due to a cut was observed.Upon removing the a-rubber noted excessive frayed wires on the bending mesh, a physical damaged attributed to user mishandling.Since the issue of loss of image was not duplicated in evaluation, it was likely caused by temporary short-circuit of the circuit board inside the video connector because moisture or water entered into the inside of the device from a leak.Possible causes of deterioration of the circuit board can be as follows: power turned on or off while the video connector is wet.Video connector was connected and disconnected while the power was turned on.Scratch or stain of the electrical contacts of the video system center or the video connector.Application of static electricity to the electrical contacts of the video connector.Incompatible reprocessing condition such as autoclaving.

• 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: 10579827
• MDR Text Key: 211548642
• Report Number: 8010047-2020-06828
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• 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: 09/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1