MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The user¿s complaint was not confirmed.The device was visually inspected, and a 2 hour burn test was performed and unable to duplicate the user¿s complaint.The device was tested with several different scopes and found unit passed all functional tests.Video image was functioning as intended and errors did not appear.Scope socket is in normal condition; however, the front panel labeling was missing.The socket air joint was worn out and was leaking pressure and there was corrosion in the air tubing.The listed parts were replaced.The device was returned to full functionality and returned to the user facility.

Event Description

The user facility reported that the device received a b30 communication error.The device has b30 and b216 errors when different scopes are connected.A b30 error occurred and a df not connected error.There was no patient injury.No additional information was provided.This file is for the b30 error received.

Manufacturer Narrative

The investigation has been completed.As the results of the device history record review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.The root cause could not be conclusively determined.Probable causes that could have led to the reported event include that this was caused by foreign material such as dust or dirt and the remainder of the chemical solution attached to the electrical contact point of the video connectors.Scope communication errors (e216) occur when successful communication occurs at the time of activation, but a certain communication failure period subsequently occurs.The instructions for use caution: "before connecting the endoscope connector to the light source, confirm that the endoscope connector, including the electrical contacts are completely dry and clean.If the endoscope is used with the electrical contacts wet and/or dirty, the endoscope and light source may malfunction".

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10326579
• MDR Text Key: 200430342
• Report Number: 8010047-2020-04848
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

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: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 11/16/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1