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

Model Number CLV-180

Device Problems Circuit Failure (1089); Mechanical Problem (1384); Defective Component (2292); Component or Accessory Incompatibility (2897)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The device evaluation confirmed the user report.The device had a non-olympus lamp reading over 500 hours (expired).The light intensity measure was also out of range.There was also a missing hexagon wrench inside the lamp door, the high intensity function was not working due to a worn out scope socket and slider switch, the iris printed circuit board was stuck intermittently, and there was a charred fuse component on the socket switch regulator that indicated a defective switch regulator.Further, a review of the device history record (dhr) and a review of the instructions for use (ifu) were conducted as part of the investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statement: "never install a lamp that has not been approved by olympus.The use of a non approved lamp can cause damage to the light source and ancillary equipment, malfunction or a fire." the root cause of the user report (lighting issues) is traced to a failure to follow the ifu.In addition, the probable cause of the evaluation findings (charred fuse component, worn scope socket and slider switch, and defective circuit board) can be traced repeated use for a long period of time, as it has been over 11 years since the manufacturing date.The missing hex wrench on the lamp cover is assumed to be stored in a different location.Olympus will continue to monitor the performance of this device.

Event Description

It was reported there was a lighting issue with the evis exera ii xenon light source.No patient harm or impact to patient care was reported.

• Brand Name: EVIS EXERA II 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11293619
• MDR Text Key: 231442471
• Report Number: 8010047-2021-02375
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170216961
• UDI-Public: 04953170216961
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2021

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: CLV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 02/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1