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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. BIOPSY NEEDLE Back to Search Results
Model Number NA-201X-4021
Device Problem Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 07/29/2021
Event Type  malfunction  
Event Description
The needle lock function failed, preventing staff from securing needle while entering and exiting the airway.
 
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Type of DeviceBIOPSY NEEDLE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
800 west park drive
westborough MA 01581
MDR Report Key12525461
MDR Text Key273101868
Report Number12525461
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 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberNA-201X-4021
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 FDA09/10/2021
Event Location Hospital
Date Report to Manufacturer09/24/2021
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 Unkown

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