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 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc checked the subject device and confirmed that the glass part has a crack.Omsc surmised that the cause of this event is the following in theory.By the influence of the unintended temperature rise, the thermal stress was applied to the glass part.The crack occurred in the glass part by this thermal stress.The xenon gas of this lamp leaked from this crack.As a result, this phenomenon occurred.Omsc surmised that the factor of the unintended temperature rise is the following.The vent of the clv-s40pro was blocked.So the internal temperature of clv-s40pro became high.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

After the user anesthetizes the patient, the endoscopic image became dark before the user started unspecified knee arthroscopic procedure using the visera pro xenon light source clv-s40pro.The user replaced the clv-s40pro with another otv-s7v system and completed the procedure.The subject md-631 was removed from the clv-s40pro and was checked.The glass part of the subject md-631 had a crack.There was no report of the patient injury other than replacing the device.

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
• MDR Report Key: 7435107
• MDR Text Key: 106148072
• Report Number: 8010047-2018-00653
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• PMA/PMN Number: PK954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MD-631
• Other Device ID Number: 04953170355950
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1