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

Model Number CV-180

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device has been returned for evaluation.The customer¿s complaint of the sdi output not working was confirmed.The service technician observed a faulty printed circuit board.In addition, a worn out video connector latch was causing poor connection.Replaced listed parts.Software (b)(6) installed and nbi unlocked.Housing was found in normal condition.Unit passed electrical leak test and all functional tests.All video output signals and images tested okay.The most likely cause traced to an electrical component failure.No further information was reported.

Event Description

The customer reported to olympus that the device's serial digital interface (sdi) output was not working.There was no patient injury reported.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.There is also a correction, information provided by customer but not included in the initial mdr.Please see the updates in sections: e2, e3, g4, g7, h2, h3, h4, h6, and h10.Correction information is the initial reporter¿s occupation is secretary.The event took place during preparation for use.The device was inspected and there was no damage or abnormalities observed.The monitor was compatible with the sdi.The proper cable was used to connect the monitor to the device.The device was set up and installed correctly.The issue with the device was the output was not sending a signal out.There was no damage or abnormalities observed with the cords.The device history record review confirmed that device there were no abnormalities, special adoption, or variations in manufacturing.Device has been returned for evaluation.Upon inspection and testing, sdi output not working.This is attributed to the faulty dp board.The customer¿s complaint of the sdi output not working was confirmed.In addition, worn out video connector latch is causing poor connection.Root cause of the issue could not be conclusively determined.It is likely that the dp board equipped with the sdii connector failed due to long-term use and the event occurred.The worn out video connector latch can be attributed to wear due to long term usage or application of excessive force to the locking lever (video connector socket) and the video connector due to handling in a way not described in the instruction manual.The instructions for use includes the following statements: ¿ 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 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.¿ do not connect or disconnect the endoscope connector while this video system center is turned on.Connecting or disconnecting the endoscope while this video system center is on may destroy the ccd.Turn the video system center off before connecting or disconnecting the endoscope.

• 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: 10179086
• MDR Text Key: 199464406
• Report Number: 8010047-2020-03536
• 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: 10/13/2020

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: 05/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1