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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. RHINO-LARYNGO VIDEOSCOPE; FLEXIBLE VIDEO LARYNGOSCOPE
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OLYMPUS MEDICAL SYSTEMS CORP. RHINO-LARYNGO VIDEOSCOPE; FLEXIBLE VIDEO LARYNGOSCOPE Back to Search Results
Model Number ENF-V3
Device Problem Fluid/Blood Leak (1250)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 04/27/2022
Event Type  Injury  
Event Description
The customer reports during reprocessing of a rhino-laryngo videoscope, leaking was found at the bending section.Prior to reprocessing, the scope was used in an unspecified procedure.It is reported the patient experienced an unspecified injury during that procedure.Additional details have been requested, at this time, no additional information has been provided.
 
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Brand Name
RHINO-LARYNGO VIDEOSCOPE
Type of Device
FLEXIBLE VIDEO LARYNGOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key14515716
MDR Text Key292738721
Report Number2951238-2022-00410
Device Sequence Number1
Product Code EOB
UDI-Device Identifier04953170310416
UDI-Public04953170310416
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/28/2022,05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberENF-V3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date04/28/2022
Event Location Hospital
Date Report to Manufacturer04/28/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/26/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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