MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H290Z

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

Olympus medical systems corp.(omsc) could not investigate the subject device, because the subject device was not returned to omsc.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Since the subject device was not returned to omsc, the exact cause was unknown.Omsc surmised that the reported phenomenon occurred due to the following cause.-the user did not check that the reprocess was completed normally according to the instruction manual.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that after the user used the subject device for the procedure, the subject device was not reprocessed and was used for next procedure.The subject device was placed in the reprocessing basin of the oer-3 but a staff did not start the reprocess program of the oer-3.Another stuff judged that the reprocess was completed and took it for the next procedure.Other detailed information was not provided.There was no report of patient injury associated with the event.

• Brand Name: EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11972255
• MDR Text Key: 280677320
• Report Number: 8010047-2021-07320
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H290Z
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1