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

Model Number LTF-S190-5

Device Problem Poor Quality Image (1408)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The user¿s complaint was not confirmed.No findings available.The cause could not be determined.No further information was reported.A supplemental will be submitted if new information becomes available or the device is returned.

Event Description

The user facility reported that the device had bending manipulation and insertion tube defects as the incorrect shape or angle of the bending camera would not toggle up and down.It was also reported that the picture continued to blink on and off.There was no patient involvement.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), device unique identifier (udi) number and investigation conclusion.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the reported issue was not identified.Device was not returned for evaluation.Based on reported information of bending section/angulation abnormality, it was presumed that outer stress may have been added to bending section, the stress may have caused (charge coupled device)ccd cable to kinked/broken which led to the reported phenomenon.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: do not twist or bend the bending section with your hands.Equipment damage may result.Do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.Do not attempt to bend the endoscope¿s insertion section with excessive force.Otherwise, the insertion section may be damaged.Olympus will continue to monitor complaints for this device.

• 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: 10478576
• MDR Text Key: 224914997
• Report Number: 8010047-2020-06069
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTF-S190-5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1