MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA ELITE XENON LIGHT SOURCE

Model Number CLV-S190

Device Problem Break (1069)

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

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus¿s local distributor, but not returned to omsc.In the evaluation of the omsc the following was confirmed on information from the local distributor, there was no key tone on the front panel due to defective electrical board.Serial no:(b)(4) (date of manufacture: may 31th, 2018).Repair history: no repair history found for the past year.The local distributor confirmed malfunction of the electrical board.As a result of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.No repair history found for the past year.The electrical board controls light adjustment, lamp, communication between otv-s190, and front panel.Therefore, omsc assumed that accidental malfunction of parts on the electrical board caused defective electrical board, led to defective front panel or unstable control signal with otv-s190, no key tone resulted.

Event Description

Olympus medical systems corp.(omsc) was informed from user facility that the key buttons don't have corresponding sounds when pressing.There was no patient injury reported.The subject device was returned to olympus¿s local distributor.In the evaluation of the local distributor the following was confirmed, the device has been found that the buttons don't sound due to the damaged electrical board.

• Brand Name: VISERA ELITE 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: 12298955
• MDR Text Key: 265806173
• Report Number: 8010047-2021-10008
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2021

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: No Information
• Device Model Number: CLV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2018
• 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