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

Model Number CLV-190

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The unit was returned to the service center for evaluation.Estimations reported that the customer¿s complaint of ¿b30 (scope communication) and ¿e216¿ (cv-190 error message meaning the same as b30) error message¿ was confirmed.The unit¿s locking mechanism of the scope socket was found faulty and not engaging.The unit was checked with a test scope socket and the unit passed functional inspection.Minor cosmetic wear and tear were noted on the unit.The non-olympus lamp was noted to have more than 400 hours with an intensity value of 497.Estimations recommends if the ¿e216¿ error persists on the cv-190, the customer be advised to seek technical support.The cause of the scope socket failure could not be determined.The investigation of this event is ongoing and if additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed that during preparation for use, the clv-190 displayed an ¿b30 and e216¿ error messages with four different scopes.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer investigation and device evaluation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer was unable to determine the root cause.The device was delivered to the customer on july 22, 2014.The lm reported that the most probable cause for the reported event is as follows: it is speculated that the locking mechanism of the scope socket was broken, resulting in a disturbance in the communication between the scope and video processors via the light source device, resulting in a scope communication error (b30, e216).Since the device has been manufactured and delivered for more than 6 years, it is speculated that the locking mechanism of the scope socket has been abraded by repeated use for a long period of time.It is assumed that the user did not notice (or ignore) the description in ifu and attached the desired lamp (non-specified product).

• 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: 11340426
• MDR Text Key: 232590416
• Report Number: 8010047-2021-02780
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• PMA/PMN Number: EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

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-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 04/02/2021
• Supplement Dates FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1