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

Model Number CV-180

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Patient Involvement (2645)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

The unit was not returned to the service center for evaluation.A review of the instrument history showed no service/repair record since the date of purchase on (b)(6) 2009.As part of our investigation, the technical assistance center (tac) assisted the customer with troubleshooting.The customer informed tac that the 12ft sdi cable would stretch the length of the room.The customer determined that the cable was issue and that it needed to be replaced.Since, the unit or cable was not retuned the exact cause of the reported event cannot be determined at this time.The investigation of this event is ongoing and if additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed that the unit exhibits an intermittent image, when the serial digital interface (sdi) cable is moved.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer investigation and device evaluation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer was unable to determine the root cause.The unit was delivered to the customer on december 17, 2009.The lm reported that the most probable cause for the reported event is as follows: there is no abnormality in the device, and it is presumed that the cause was that the sdi cable was about to break.As a result of checking the dhr, it was confirmed that there were no manufacturing abnormalities, special hires, or variations.

• 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: 11313008
• MDR Text Key: 233825899
• Report Number: 8010047-2021-02518
• 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
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1