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

Model Number CV-180

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device power button on cv-180 exera ii cart was found cracked.There was no patient involvement on this event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The following sections were updated: g4, g7, h2, h4, h6 and h10.The customer replaced the power switch.Based on the results of the investigation, the event was likely due to the power switch braking down from repeated use for a long period of time, or it was damaged by the user hitting a hard object on it.Handling of the device is described in the instruction manual and this may prevent event, "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: 11135579
• MDR Text Key: 238358241
• Report Number: 8010047-2021-01037
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CV-180
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1