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

Model Number CV-180

Device Problems No Display/Image (1183); Electrical /Electronic Property Problem (1198); Failure to Power Up (1476)

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

Event Date 07/28/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed from the user facility that during the preparation for a diagnostic gastroscopy procedure using the subject device, it was found that the endoscopic image of the subject device was not displayed on the monitor.There was no report of patient injury associated with this event.

Manufacturer Narrative

The subject device was not returned to omsc for evaluation but was returned to olympus europa se & co.Kg (oekg).Oekg checked the subject device and found that the reported phenomenon was duplicated, and also found that the front panel of the subject device was broken and the power of the subject device was not turned on.The exact cause has been under investigation.Therefore, 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 olympus medical systems corp.(omsc) for evaluation but was returned to olympus europa se & co.Kg (oekg).Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomena (no image and power up failure) could not be conclusively determined.However, based upon the information from oekg, omsc surmised that the reported phenomena were attributed to the failures of the front panel and the internal components such as the printed circuit board or the power supply unit, which might be caused by the strong impact (dropping of the device, collision of hard objects, etc.).If additional information is received, 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: 12381349
• MDR Text Key: 280775606
• Report Number: 8010047-2021-10897
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1