MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. XENON LAMP

Model Number MD-631

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

The subject md-631 was returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed that the subject md-631 did not light up and the reported phenomenon could be reproduced.Omsc confirmed the crack on the glass part of the subject md-631.From above evaluation results, omsc surmised that the reported phenomenon was caused by leaking xenon gas of the subject md-631 from the crack.Omsc checked the device history record of the subject device, and there was no irregularity found.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

At the final step of the esd, the subject md-631 in the clv-260 nbi did not light up and the emergency lamp lighted up.The user turned off and re-turned on the clv-260nbi, but the phenomenon was not solved.The user replaced the subject md-631 mounted in the clv-260nbi with a spare md-631 and completed the procedure.There was no report of the patient¿s injury regarding this event.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: XENON LAMP
• Type of Device: XENON LAMP
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6803064
• MDR Text Key: 83223028
• Report Number: 8010047-2017-01214
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MD-631
• Device Lot Number: 6CBC2809
• Other Device ID Number: 04953170355950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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