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

Model Number CLV-S40PRO

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus service operation repair center (sorc).A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at olympus service operation repair center (sorc) on (b)(6) 2021, it was found that the ac power inlet of the subject device was burnt.Other detailed information was not provided.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) could not review the device history record of the subject device because more than 15 years have passed since the subject device was manufactured.The exact cause of this event could not be conclusively determined.

• Brand Name: VISERA PRO 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: 13234650
• MDR Text Key: 289347494
• Report Number: 8010047-2022-01298
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

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: Other
• Device Model Number: CLV-S40PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/12/2022
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1