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

Model Number CV-180

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2021

Event Type  malfunction  

Manufacturer Narrative

Olympus inspected the device at the service department of olympus trading (b)(4) and found followings; the device failed to boot because the power supply unit was burned out.The repair history of this device showed that it had not been repaired in the last year.The exact cause of the reported event has not yet been identified by legal.Manufacturer olympus medical systems corp.(omsc) for this device.If significant additional information is received, this report will be supplemented.

Event Description

A customer found that two fuses of the device were burnt during preparation for use.The device was used in combination with the olympus light source clv-180.The customer replaced these fuses, but the device did not turn on.The user replaced the device to another device and completed a gastroscopy.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Olympus medical systems corp.(omsc) assumed that the reported event was caused by burnout around the fuse socket due to deterioration.This deterioration may have been caused by long-term use.If significant additional information is received, this report will be supplemented.

• 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: 11782243
• MDR Text Key: 270913200
• Report Number: 8010047-2021-05918
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CV-180
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1