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

Model Number CV-180

Device Problem Poor Quality Image (1408)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The evaluation found the video connector unit latch was found loose causing an unstable flickering image.Additionally, the external housing was observed to have cosmetics scratches on top cover, faded front panel.The device was repaired to standard specifications and returned to asset inventory.The asset was last repaired to specification on (b)(6) 2017.Due to no image/worn connector contact pins.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

During a standard service inspection of an asset, evis exera ii video system center, the video connector unit latch was found loose causing an unstable flickering image.There was no report of any problems associated with the device and no patient injury or harm was reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.The cause of the failure cannot be conclusively determined.It is possible that repeated use for a long period of time resulted in a deterioration of the locking lever.Alternatively, it is possible that foreign debris remained inside the coupler, preventing a proper connection.It is also possible that the user attempted to pull out the video connector without lowering the locking lever or excessive force was applied to the locking lever (the video connector socket) and the video connector, and then the video connector lock failed.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.The instructions for use states: do not touch the electrical contacts inside the video system center's connectors.Make sure that the video plug and its electrical contacts are completely dry before connecting the plug to the video system center (see figure 4.2).Wet equipment could cause the image to flicker or disappear.Do not clean the videoscope cable socket, the terminals and the ac mains power inlet.Cleaning them can deform or corrode the contacts, which could damage the video system center.Do not apply excessive force to this video system center and/or other instruments connected.Otherwise, damage and/or malfunction can occur.

• 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: 11181340
• MDR Text Key: 242877752
• Report Number: 8010047-2021-01489
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170215513
• UDI-Public: 04953170215513
• 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
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1