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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. MAINTENANCE UNIT
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OLYMPUS MEDICAL SYSTEMS CORP. MAINTENANCE UNIT Back to Search Results
Model Number MU-1
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/22/2020
Event Type  malfunction  
Manufacturer Narrative
The device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
 
Event Description
The ac inlet of the device was broken.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The device was not returned to olympus medical systems corp.(omsc), therefore omsc cannot investigate the device.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.
 
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Brand Name
MAINTENANCE UNIT
Type of Device
MAINTENANCE UNIT
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key10732515
MDR Text Key224661103
Report Number8010047-2020-08146
Device Sequence Number1
Product Code KNT
UDI-Device Identifier04953170060434
UDI-Public04953170060434
Combination Product (y/n)N
PMA/PMN Number
K051645
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberMU-1
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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