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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HALOGEN LIGHT SOURCE

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OLYMPUS MEDICAL SYSTEMS CORP. HALOGEN LIGHT SOURCE Back to Search Results
Model Number CLK-4
Device Problem Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Date 02/21/2020
Event Type  Malfunction  
Manufacturer Narrative

The returned asset device was sent to the service center for evaluation. The evaluation found the air pressure was low due to faulty air pump unit & worn out air joint unit & connector socket. In addition, found two of the halogen lamps were missing inside. The top cover, bottom chassis was deformed & the front panel was damaged. The four feet at the bottom of he unit were worn out. The asset device was repaired and returned to inventory. A review of the repair records show the asset was last serviced on (b)(6) 2017 and met standard specification. No repairs were performed as the device was returned to asset inventory. The original equipment manufacturer (omsc) could not perform a device history record review because the production date is unknown. The omsc shipped the device on (b)(6) 2002. Based on the investigation results, the potential causes of the reported lamp failure may be attributed to the following: the lamp may have blown, but more than 17 years have passed since it was delivered, and it is assumed that the thermal fuse failed because lamp replacement is considered user-friendly. It is considered probable that the thermal fuse was blown due to an accidental failure of the thermal fuse or overheating in the device, because the thermal fuse was not restored. The temperature fuse might have blown out because the user had put other equipment on the air intake and exhaust ports, etc. , and it was used in an environment in which the conditions of intake and exhaust were bad. As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: the light source ventilation grill and openings should be clear of ancillary equipment. Blockage can cause overheating and equipment damage.

 
Event Description

The sales representative reported an out of the box failure; during inspection the halogen light source lights would not come on. No patient involvement was reported. The light source will be returned for a new unit.

 
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Brand NameHALOGEN LIGHT SOURCE
Type of DeviceHALOGEN LIGHT SOURCE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key11026884
MDR Text Key222098718
Report Number8010047-2020-10558
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK993041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 12/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberCLK-4
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/23/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/19/2020
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 Reuse

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