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

Model Number CV-180

Device Problem No Display/Image (1183)

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

Event Type  malfunction  

Manufacturer Narrative

As the device was not returned to olympus for evaluation, a root cause for the reported event cannot be determined.If additional information becomes available or the device is returned for evaluation, a supplemental report will be submitted.

Event Description

A user facility reported to olympus that the image was intermittently lost during a procedure.There was no patient injury, associated with the problem, reported to olympus.

Manufacturer Narrative

This supplemental report is submitted to provide a correction to the initial mdr.Updates to section h6.The device was evaluated onsite by an olympus field service engineer (fse).The fse was unable to confirm or duplicate the reported problem of "image was intermittently lost." the fse verified equipment functionality with no problems noted with the subject device.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation.Updates to sections d8, h4 and h6.Correction to field d9.The device history record for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A definitive root cause could not be identified.Based on the available information, the investigation determined that since the reported problem could not be reproduced or confirmed during the device evaluation, the likely cause of the reported event was an episodic impact from connection with another device used in combination or the circumstance of the facility.

• 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: 11741868
• MDR Text Key: 269416761
• Report Number: 8010047-2021-05585
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1