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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. XENON LAMP Back to Search Results
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".
 
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Brand NameXENON LAMP
Type of DeviceXENON LAMP
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
MDR Report Key7435107
MDR Text Key106148072
Report Number8010047-2018-00653
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
PMA/PMN Number
PK954451
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received04/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMD-631
Other Device ID Number04953170355950
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2019
Is This a Reprocessed and Reused Single-Use Device? No

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