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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. RHINO-LARYNGOFIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. RHINO-LARYNGOFIBERSCOPE Back to Search Results
Model Number ENF-T3
Device Problem Failure to Disinfect (1175)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The subject device in this report has not been returned to 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
Olympus medical systems corp.(omsc) was informed that the user facility had only wiped the insertion part with alcohol after using the subject device.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.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, however there was the possibility that this phenomenon was attributed to the user mishandling.If additional information becomes available, this report will be supplemented.
 
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Brand Name
RHINO-LARYNGOFIBERSCOPE
Type of Device
RHINO-LARYNGOFIBERSCOPE
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 Key10019929
MDR Text Key209215028
Report Number8010047-2020-02462
Device Sequence Number1
Product Code EOB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K011869
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/24/2020
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 Health Professional
Device Model NumberENF-T3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/09/2020
Initial Date FDA Received05/04/2020
Supplement Dates Manufacturer Received05/20/2020
Supplement Dates FDA Received05/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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