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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE NA-U201H
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AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE NA-U201H Back to Search Results
Model Number NA-U201H-8022
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 07/13/2022
Type of Reportable Event Serious Injury
Event or Problem Description
The customer reports during an unspecified procedure using a single use aspiration needle, the needle broke off inside the patient (inside the tumor).It is unknown if the needle was successfully retrieved.Additional details regarding the patient and reported event have been requested.At this time, no additional information has been provided.
 
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Brand Name
SINGLE USE ASPIRATION NEEDLE NA-U201H
Common Device Name
ASPIRATION NEEDLE
Manufacturer (Section D)
AOMORI OLYMPUS CO., LTD.
2-248-1 okkonoki
kuroishi-shi, aomori 036-0 357
JA  036-0357
MDR Report Key15198957
Report Number2429304-2022-00018
Device Sequence Number6414090
Product Code FCG
UDI-Device Identifier04953170402586
UDI-Public04953170402586
Combination Product (Y/N)N
Initial Reporter StateAL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/10/2022
Report Date (Section F) 07/14/2022
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
Operator of Device Health Professional
Device Model NumberNA-U201H-8022
Device Lot Number22K
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date07/14/2022
Event Location Hospital
Date Report to Manufacturer07/14/2022
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/10/2022
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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