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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 Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/22/2019
Event Type  malfunction  
Manufacturer Narrative
The subject device was not yet been received for evaluation. The cause of the reported event cannot be determined. A supplemental report will be filed if and when the product is returned and investigation has been completed. As a preventive measure, the instruction manual states: when inserting the instrument into the endoscope, the distal end of the needle tube may be bent. When piercing the target, confirm the distal end of the sheath and needle tube in the endoscopic field of view and/or ultrasound image while considering such bending. Otherwise, patient injury such as perforation, bleeding, or mucous membrane damage may occur. Do not try to straighten a bent or deformed needle with your hands because the needle may break.
 
Event Description
It was reported that the user had finished the procedure and noticed that the tip of the needle broke off and fell into the patient¿s airway. The user removed the tip of the needle from the patient and there was no harm or injury reported due to the event.
 
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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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key9347485
MDR Text Key219780835
Report Number8010047-2019-04032
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160098
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNA-U401SX-4021
Device Lot NumberPW305580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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