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

Model Number CLV-S40PRO

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) found that during an unspecified procedure of the subject device, the main light does not turn on and the light switched from main light to emergency light.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.In the evaluation of omsc the following was confirmed; the phenomenon did not reproduce; the lamp hour indicator on the front panel displayed the total accumulated operating hours was 300.The fuse box of the inlet was burnt.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The cause is presumed to be that the xenon lamp went out due to a temporary malfunction of the power supply unit.If additional information becomes available, this report will be supplemented.

• 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
• MDR Report Key: 10031609
• MDR Text Key: 222527936
• Report Number: 8010047-2020-02527
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-S40PRO
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1