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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 Problem Activation, Positioning or SeparationProblem (2906)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 03/19/2020
Event Type  Injury  
Event Description
It was reported that excess force was required to deploy the needle during a lymphadenopathy. The procedure was completed planned. Following the procedure, the user experienced a needle stick as the needle was not retracted into the sheath when it was given to her. It was noted the cause of this is unknown. As a result of the needle puncture, a report was filed in house, the user received a tetanus shot and was tested for (b)(6) along with the patient. They both tested (b)(6). The user is in stable condition. The user's reported weight is (b)(6) pounds. The device was not returned to olympus for evaluation. As reported, the event occurred a result of the needle not being retracted into the sheath. It was noted the cause of this is unknown.
 
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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
MDR Report Key10101603
MDR Text Key195125512
Report Number2951238-2020-00449
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,Followup
Report Date 05/22/2020,06/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNA-201SX-4022
Device Lot Number99V
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date05/22/2020
Event Location Hospital
Date Report to Manufacturer05/22/2020
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: 05/29/2020 Patient Sequence Number: 1
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