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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE Back to Search Results
Model Number NA-201SX-4022
Device Problems Break (1069); Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/30/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device has not yet been received for evaluation. The cause of the issue cannot be determined at this time. If additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported that during an endobronchial ultrasound bronchoscopy (ebus) procedure, the user determined that the needle was not visible beyond the sheath when it was advanced. The user looked everywhere , used ultrasound to check all the puncture sites including fluoro checks. The user ended up finding the tip of the needle on the back table where the user prepared the tissue samples. According to the reporter, the user suspected that the needle might have broken in the patient on a previous pass and got lodged in the sheath, slipped out during the sample preparation. There was no patient harm or impact due to the incident. No user harm or injury was reported.
 
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Brand NameSINGLE USE ASPIRATION NEEDLE
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 Key10134691
MDR Text Key194528659
Report Number8010047-2020-03235
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNA-201SX-4022
Device Lot Number99V
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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