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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OME9-TBI-W-N1; OPERATION MICROSCOPE
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OLYMPUS MEDICAL SYSTEMS CORP. OME9-TBI-W-N1; OPERATION MICROSCOPE Back to Search Results
Model Number OME9-TBI-W-N1
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The subject devices have not been returned to omsc but were returned to olympus service operation repair center (sorc) for evaluation.Sorc checked the subject device and found that the reported phenomenon was duplicated.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.If additional information is received, this report will be supplemented.
 
Event Description
Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at olympus service operation repair center, it was found that left and right eyeshades were torn.There was no report of patient injury associated with the event.
 
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Brand Name
OME9-TBI-W-N1
Type of Device
OPERATION MICROSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key12695058
MDR Text Key281983161
Report Number8010047-2021-13627
Device Sequence Number1
Product Code IZI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberOME9-TBI-W-N1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/30/2021
Initial Date FDA Received10/26/2021
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 Unknown
Patient Sequence Number1
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