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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 Optical Problem (3001)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2018
Event Type  malfunction  
Manufacturer Narrative
The subject md-631 was returned to olympus medical systems corp. (omsc). The subject md-631 and devices (omsc asset) were connected to check the operation of the subject md-631. As a result, the intensity of the light emitted by the subject md-631 was weak. The similar phenomenon as reported malfunction was reproduced. Moreover, a minute crack was detected in the lamp surface by visual examination of the outer surface of the subject md-631. It is considered that xenon gas sealed inside the lamp leaked from the minute crack and could cause the reported phenomenon. Approximately three years and nine months have passed since the subject md-631 was manufactured. There is a possibility that the crack occurred by using it for a long time.
 
Event Description
During an unspecified polypectomy procedure using the md-631, the intensity of the light emitted by the subject md-631 became weak. The user replaced the light source device including the subject md-631 with another similar device and completed the procedure. In the light source device including the md-631, the malfunction was resolved by replacing the subject md-631 with another lamp. There was no report of the patient¿s injury regarding this event other than the replacement of the subject 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 Key7576684
MDR Text Key110338958
Report Number8010047-2018-01019
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
PMA/PMN Number
K954451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
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 Received06/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMD-631
Device Lot NumberNO INFORMATION
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2018
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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