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

Model Number CV-180

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus and evaluated.The unit was tested with multiple scopes and no sparking was observed.The reported problem could not be duplicated and a root cause was not determined; however, the evaluation found the top cover corroded, bottom chassis corroded, front panel chassis corroded, a damaged front panel and worn video connector pins, causing an unstable image when manipulating (i.E., wiggle) the pigtail.

Event Description

A user facility reported to olympus that they observed sparks from the video socket connector when the scope was connected.There was no patient injury or harm, associated with the problem, reported to olympus.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Due to the issue not being reproduce in the repair department and based on the results of the investigation, the probable cause is likely the spark was caused by static electricity discharge.Per the legal manufacturer, the other device defects included in the initial mdr (corrosion, damaged front panel, worn video connectors) have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.

• 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: 11181632
• MDR Text Key: 240588460
• Report Number: 8010047-2021-01493
• 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: 03/01/2021

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: 01/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1