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

Model Number CV-180

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to omsc for evaluation but was returned to olympus (b)(4) (osp).(b)(4) checked the subject device and found that the reported phenomena were duplicated due to the failure of the video connector socket and the printed-circuit board.Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity.The subject device was delivered to the user on (b)(6) 2021 and the reported phenomena were occurred after only three days from the delivered.However, based upon the information from (b)(4), omsc surmised that the reported phenomena were attributed to the failure of the video connector socket and the printed-circuit board due to the aging deterioration because over ten years had passed from the subject device had been manufactured.Omsc surmised that the user had purchased the subject device which had failure of the video connector socket and the printed-circuit board.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during unspecified timing, it was found that the endoscopic image was displayed intermittently and the color bar image was displayed.There was no report of patient injury associated with the event.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12038170
• MDR Text Key: 257455970
• Report Number: 8010047-2021-07796
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1