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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-4022
Device Problems Output Problem (3005); Physical Resistance/Sticking (4012)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 08/14/2019
Event Type  Injury  
Event Description
The company representative indicated that two needles failed during an endobronchial ultrasound (ebus) procedure. The 21 g needle failed to lock into the scope. The doctor was not able to move the handle of the device downward, which caused an inability to obtain a tissue sample. The doctor used a second 22 g needle and was able to push the handle down in order to collect a sample. However, he was unable to push the needle back into the sheath. The inability to retract led to the needle being ¿stuck¿ in the patient. Some bleeding post removal occurred that the interventionalist was able to manage with cryotherapy. No other patient issues were reported.
 
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Brand NameSINGLE USE ASPIRATION NEEDLE NA-U401SX
Type of DeviceSINGLE 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 Key9016591
MDR Text Key158111335
Report Number2951238-2019-01114
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 09/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNA-U401SX-4022
Device Lot NumberFR846004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/12/2019
Distributor Facility Aware Date08/14/2019
Event Location Hospital
Date Report to Manufacturer08/14/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/12/2019 Patient Sequence Number: 1
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