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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U401SX

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U401SX Back to Search Results
Model Number NA-U401SX-4021
Device Problem Device Slipped (1584)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/24/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to olympus medical systems corp.(omsc).The exact cause has been under investigation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
 
Event Description
During an unspecified procedure, the subject device was used.The needle adjuster lever could not be locked.The intended procedure was completed with another device.There was no patient injury reported.This is the report regarding the inability to fix the needle tube.
 
Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The insertion portion and the handle section were not deformed or buckled.As a confimation result of the lock mechanism and the smoothness of the needle adjuster lever, there was no abnormality.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the needle adjuster lever could not be fixed since the needle adjuster was fixed to the convex position instead of the groove at the handle.The above device handling has warned in the instruction manual as follows.*before pushing the needle slider, confirm that the needle adjuster is fixed firmly.Be sure to firmly fix the needle adjuster.Otherwise, it could cause excess extension of the needle from the distal end of the sheath and perforation, bleeding, or mucous membrane damage may result.*if you feel excessive resistance while operating the needle adjuster lever, release the needle adjuster lever once and fix it again.Otherwise, it could damage the needle adjuster lever and patient injury, such as perforation, bleeding, or mucous membrane damage could result.
 
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Brand Name
SINGLE USE ASPIRATION NEEDLE NA-U401SX
Type of Device
SINGLE USE ASPIRATION NEEDLE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key10073644
MDR Text Key209013010
Report Number8010047-2020-02800
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
PMA/PMN Number
K160098
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberNA-U401SX-4021
Device Lot Number9YK
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2020
Was the Report Sent to FDA? No
Date Manufacturer Received07/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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