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

Model Number LTF-S190-10

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus service operation repair center was informed from the facility that during an unspecified procedure using the subject device, the subject device gave error e218 which indicated the endoscope was damaged.Thus, the facility replaced the subject device to a similar 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.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, 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: 9936589
• MDR Text Key: 208765779
• Report Number: 8010047-2020-02040
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K111425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LTF-S190-10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1