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

Model Number CV-180

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.During the evaluation, the housing contained dust inside and out.A loose video connector latch was found causing an unstable flickering image.The software version was upgraded to the latest.No other issues were found during the device inspection.If additional information is obtained a supplemental report will be filed.

Event Description

A user facility sent a video system center to olympus for an annual inspection.No device problems were reported at the time.No patient involvement or injuries were reported.No additional information has been obtained.

Manufacturer Narrative

The investigation has been completed.A device history record (dhr) review was performed and found no non-conformances that would cause the reported malfunction.All records indicate that the device was manufactured in accordance with all applicable procedures.The instructions for use (ifu) states: ¿do not apply excessive force to the camera cable of the camera head by bending, stretching or crushing it.Also do not pull a bundle of camera cables, as this may cause internal wire disconnection.Do not connect or disconnect the endoscope connector while this video system center is turned on.Connecting or disconnecting the endoscope while this video system center is on may destroy the ccd.Turn the video system center off before connecting or disconnecting the endoscope.¿.The root cause could not be conclusively determined.Probable causes that could have led to the reported event include that the lock or the pin on the receptacle unit was worn away due to repeated use for a long period and failed.

• 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: 11222612
• MDR Text Key: 228477055
• Report Number: 8010047-2021-01832
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1