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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
Catalog Number NA-201SX-4022
Device Problems Activation, Positioning or SeparationProblem (2906); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/16/2019
Event Type  malfunction  
Event Description
The physician felt like the needle didn't feel right and was stiff going in. When he attempted to do a biopsy, the device did not seem to work as smoothly as usual. It was removed from the patient and found to have a large bend in it.
 
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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 Key9495498
MDR Text Key172023583
Report Number9495498
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 10/25/2019,10/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNA-201SX-4022
Device Lot NumberV8X08
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/25/2019
Event Location Hospital
Date Report to Manufacturer12/19/2019
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

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