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

Model Number CV-180

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

Olympus technical assistance center (tac) personnel attempted to troubleshoot the device with the customer but was unsuccessful.The customer noted that they would continue the procedure, and attempt further troubleshooting afterward.Follow up attempts with the user facility have been unsuccessful.At this time it does not appear the device will be returned.However, should additional information become available prior to the conclusion of the investigation, a supplemental report will be provided.

Event Description

It was reported, the biomedical engineer was attempting to troubleshoot the evis exera ii video system center as it was receiving poor quality and intermittent images.According to the initial reporter, the staff needed to hold the scope a specific way to maintain the image.Furthermore, when an image was present it would sometimes have a black line through it.There was no patient harm or consequence reported as a result of this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.Because the device was not returned to olympus for an evaluation, the cause of the reported issue cannot be conclusively determined.The following are some potential causes, based on product knowledge: more than 11 years have passed since the device was delivered, and it is assumed that the lock and pins of the video connector worn out due to repeated use for a long period of time, resulting in a failure.Or, it is inferred that the connector lock failure occurred due to the user's application of force such as forcibly connecting the scope connector, diagonally connecting, excessive bending, pulling, twisting, crushing, etc.Or, it is assumed that it occurred because the corrosion of the connector occurred because the user left the foreign matter such as dust and dirt and the residue of the liquid adhering.As a result, the electrical contact of the connector becomes unstable, it interferes with the image transmission between the scope and the video processor, it is speculated that the phenomenon of the image flickering occurred.In addition, it is assumed that the phenomenon in which the image disappears by the operation of the scope connector occurred because the lock is unstable.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.The instructions for use states: do not touch the electrical contacts inside the video system center's connectors.Make sure that the video plug and its electrical contacts are completely dry before connecting the plug to the video system center (see figure 4.2).Wet equipment could cause the image to flicker or disappear.Do not clean the videoscope cable socket, the terminals and the ac mains power inlet.Cleaning them can deform or corrode the contacts, which could damage the video system center.

• 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: 11414287
• MDR Text Key: 234766296
• Report Number: 8010047-2021-03321
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1