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

Model Number CV-180

Device Problem Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

During the inspection of use the subject device, the subject device could not be turned the power on.Olympus service operation repair center replaced the power supply unit of the subject device to the new power supply unit.Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

This is a supplemental report for mfr report.Olympus medical systems corp.(omsc) could not investigate the subject device, because the subject device was not returned to omsc.Since the subject device was not returned, the exact cause was unknown.The instruction manual of the subject device states the corresponding method in case of an abnormality.

Manufacturer Narrative

This report is being supplemented to provide correction and additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and since six years or more have passed since the delivery of the device, it is likely the parts of the power supply unit deteriorated and the power supply unit failed due to repeated use for a long period of time.

• 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: 10147446
• MDR Text Key: 194930201
• Report Number: 8010047-2020-03310
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2021

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: 05/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 06/25/2020; 12/24/2020
• Supplement Dates FDA Received: 07/21/2020; 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1