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

Model Number CLV-190

Device Problem Component Incompatible (1108)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The evaluation revealed: illumination light is not emitted from use of non-olympus bulbs, and confirmed the reported issue of contact difficulties at the input socket.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The customer reported to olympus there were contact problems at the input socket.There was no patient harm or user injury reported due to the event.Upon inspection and testing of the customer returned device, the repair center found illumination light was not emitted due to use of olympus non-designated lamps.This report is being submitted for the event that occurred at estimation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 8 years since the subject device was manufactured.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, the phenomenon ¿the subject device did not properly emit light¿ might have occurred because a non-olympus lamp was used.The instruction manual of clv-190 describes the following, and the following phenomenon might have been prevented by following the descriptions: illumination light is not emitted (a non-olympus lamp is used); never install a lamp that has not been approved by olympus.The use of a nonapproved lamp can cause damage to the light source and ancillary equipment, malfunction or a fire.¿ olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 20-feb-2022.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13976885
• MDR Text Key: 298209626
• Report Number: 8010047-2022-05524
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2022

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: 03/03/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 05/11/2022; 11/08/2022
• Supplement Dates FDA Received: 06/02/2022; 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2013
• 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