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

Model Number CV-180

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.The customer¿s complaint of ¿there is sections of the imaging blacking out intermittently and the screen black out is partial and complete" was not confirmed.The unit burned for over 2 hours with a test clv-180 and with our gif-h180, gif-q180 test scopes.The video image functioning normally.The unit passed all functional test and was found to have the current software version 4.00 and nbi updated.The video connector was in normal condition.

Event Description

The service center was informed that during an unspecified procedure, the image would intermittently partially or completely go black.There were no error codes, alarms, or alert tones associated with this event.All of the settings were checked and found to be correct.All of the connections and cables were also checked and found to be secured.There wasn't any foreign objects such as detergent remnants, hard water residue, finger grease, dust or lint on the electrical contacts.There weren't any other devices involved in the event.No other devices were replaced during the procedure.There wasn't any delay in the procedure in which the subject device was used.The intended procedure was completed with a similar device.There was no patient injury.Additionally, the user facility reported that the device was inspected prior to the procedure and no abnormalities were noted.The cable was also inspected and no damage was noted.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional information and device evaluation results.Please see the updates in sections: g4, g7, h2, h3, h4, h6 and h10.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.According to dhr review the subject device was shipped in accordance with specifications.The legal manufacturer reported that the unit was delivered to the customer on september 30, 2010.The legal manufacturer reported that the root cause could not be determined.The lm reported that the most probable causes for the reported event are as follows: suggested events: (1) the image does not appear.(2) the image flickers.(1)(2): as approximately 10 years or longer have passed since manufacture of this product, it is presumed that the event occurred because the video connector was used in the state where its electrical contacts wore out and deteriorated due to long-term use.Alternatively, it is presumed that as the user attempted to pull out the video connector without pushing the locking lever down or excessive force was applied to the locking lever (video connector socket) or the video connector, the lock mechanism of the video connector failed and the connection with electrical contacts could not be made correctly, resulting in occurrence of this event.The legal manufacturer reports that regarding the handling of the device, the instruction manual contains the following description.Therefore, it is presumed that the events (1) and (2) can be prevented.Do not apply excessive force to this video system center and/or other instruments connected.Otherwise, damage and/or malfunction can occur.Do not apply excessive force to the camera cable of the camera head by bending, stretching or crushing it.Also do not pull a bundle of camera cables, as this may cause internal wire disconnection.

• 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: 10764500
• MDR Text Key: 225205699
• Report Number: 8010047-2020-08351
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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: 10/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1