MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II VIDEO SYSTEM CENTER

Model Number CV-180

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 05/07/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed from the user that the image of the subject device was flickered when the camera head connected to the subject device was slightly moved during preparation for use.The user took the precaution on it during the procedure and completed the procedure with using the same set of equipment, and without the patient injury.

Manufacturer Narrative

The subject device is planned to be returned to olympus but has not been returned to olympus yet.Therefore, olympus could not investigate the subject device.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to omsc but was returned to olympus malaysia for evaluation.Olympus malaysia checked the subject device and duplicated the reported phenomenon.It was found the video connector socket failure of the subject device which made image flicking.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Based upon the information from olympus malaysia, omsc surmised that the reported phenomenon might have occurred due to loosen connector with the abrasion in the lock and contact pin of the video connector socket of the subject device because it has been more than 10 years since the subject device manufacturing.If additional information becomes available, this report will be supplemented.

• Brand Name: EVIS EXERA II VIDEO SYSTEM CENTER
• Type of Device: VIDEO SYSTEM CENTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11982556
• MDR Text Key: 280683072
• Report Number: 8010047-2021-07396
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/11/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1