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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIZISHOT BIOPSY NEEDLE

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OLYMPUS MEDICAL SYSTEMS CORP. VIZISHOT BIOPSY NEEDLE Back to Search Results
Model Number NA-201SX-4022
Device Problem Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Date 10/19/2021
Event Type  malfunction  
Event Description
While doing a procedure, the stylet from the needle wouldn't retrieve back to properly collect the specimen needed for the cytology team to examine the cells put on the slide.
 
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Brand NameVIZISHOT
Type of DeviceBIOPSY NEEDLE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2400 ringwood ave
san jose CA 95131
MDR Report Key12851498
MDR Text Key281077997
Report Number12851498
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNA-201SX-4022
Device Lot NumberOYV
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/28/2021
Event Location Hospital
Date Report to Manufacturer11/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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