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

Model Number CV-180

Device Problem Optical Problem (3001)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, the technical assistance center (tac) assisted the customer with troubleshooting.It was reported that while troubleshooting the lights on the front panel of the unit began to flash.Tac recommended that the unit be sent in for repair.The unit was returned to the service center for evaluation.The customer¿s complaint of ¿the processor the lights keep flashing on the front¿ was not confirmed.The unit¿s main switches were noted to be corroded.The unit¿s electronics were checked and found the eject button on the pc board functioned intermittently due to a faulty printed circuit board.Damage and corrosion were noted on the unit¿s front and rear panel and the chassis was deformed.The unit was repaired and returned to the customer.This investigation is ongoing and if additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed that the user facility¿s biomed the main lamp in the light source and the end user states that the light was too bright.There was no report of patient injury or patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the probable cause is likely the amount of use and age of the device (over 12 years) causing the parts on the front panel unit to be worn away and failed due to repeated use for a long period and a part of the leds did not light up.This issue is addressed in the instructions for use (ifu): "do not apply excessive force to this video system center and/or other instruments connected.Otherwise, damage and/or malfunction can occur.Do not wipe the external surface with hard or abrasive wiping material, the surface will be scratched.Store the equipment in the level position in a clean, dry and stable location.".

• 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: 11207652
• MDR Text Key: 228002674
• Report Number: 8010047-2021-01679
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• 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: 11/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1