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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP SMOOTHSHOT ASPIRATION NEEDLE
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OLYMPUS MEDICAL SYSTEMS CORP SMOOTHSHOT ASPIRATION NEEDLE Back to Search Results
Model Number NA-411D-1321
Device Problems Break (1069); Device Issue (2379); Malfunction (2409)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/28/2016
Event Type  Injury  
Event Description
Patient for bronchoscope-wang needle advanced through scope and core of tissue collected.A second biopsy attempted but on this occasion the needle seemed to be stuck in its sheath and would not pull out.The scope was then pulled out with the needle at the tip.On exam, the needle was cut.The bronchoscope was re-entered the nostril into trachea, advanced to rule where transbronchial bx done.Procedure was completed after additional biopsies removed.On 05/18/2016 - spoke with olympus representative case number provided: (b)(4).Respiratory therapy department notified company rep day after event - he came and took pictures of device.Device delivered to risk manager 05/16/2016.
 
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Brand Name
SMOOTHSHOT ASPIRATION NEEDLE
Type of Device
ASPIRATION NEEDLE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP
3500 corporate parkway
center valley PA 18034
MDR Report Key5681820
MDR Text Key46077470
Report Number5681820
Device Sequence Number1
Product Code FCG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2016
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/01/2018
Device Model NumberNA-411D-1321
Device Lot Number55K7277
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/18/2016
Distributor Facility Aware Date05/16/2016
Event Location Hospital
Date Report to Manufacturer05/18/2016
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age49 YR
Patient Weight83
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