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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 Failure to Power Up (1476)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes. A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting. Due diligence was executed for this event. Event date is not known. Supplemental report(s) will be filed as any information becomes available. The device has been returned and a device evaluation completed for it. The user¿s complaint was confirmed. Manufacturing date is not known since there is no record of the serial number; it is only known that all such devices were manufactured 2011 and before. There is no repair history on record for this device. Upon testing and inspection, it was found that the device would not power up; this is attributed to the faulty power switch on the front. In addition, found air flow rate low due to faulty air pump unit. Also round air pressure fluctuated due to worn out air joint unit, mount & connector socket. Found main lamp non-olympus type & spare lamp missing. Found front panel damaged with crack at the top. Found bottom chassis with deformity. Found top cover with minor paint scratches but still ok for re-use. The rest of other functions tested ok. Since it has been at least nine years since manufacturing of the device, it is likely that the switch is failing due to chronological deterioration due to long-term use. This also hold true for the other incidental issues observed. The user inadvertently or knowingly did not attach a lamp specified for the device. The device was returned unrepaired as manufacture of device was not on record.
 
Event Description
As reported for this event, during maintenance the device was not getting any power. There is no patient involvement and no harm reported to any patient.
 
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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 Key11185661
MDR Text Key241615128
Report Number8010047-2021-01558
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 01/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCLK-4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/09/2020
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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