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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device has been returned to olympus medical systems corp.(omsc) and it is being investigated.The exact cause of the reported event could not be conclusively determined at this time.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

The user used the subject device during an unspecified procedure.During the procedure, the endoscopic image disappeared twice.The user replaced the subject device to another unspecified device and completed the procedure.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.In the evaluation of omsc the following was confirmed; as a result of energizing the subject device for a long time, omsc could reproduce the reported phenomenon which was that the endoscopic image disappeared.Omsc disassembled the subject device.However, there were no abnormalities in the subject device.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of this reported event could not be conclusively determined, however there is possibility that this phenomenon is attributed to the accumulation of the electrical stress.There were no further details provided.If significant additional information is received, this report will be supplemented.

• 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: 9508793
• MDR Text Key: 212528235
• Report Number: 8010047-2019-04527
• 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
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1