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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE 14GA X 3 1/2"(9CM)

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ARGON MEDICAL DEVICES ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE 14GA X 3 1/2"(9CM) Back to Search Results
Model Number R640914
Device Problem Mechanical Problem (1384)
Patient Problem Needle Stick/Puncture (2462)
Event Date 07/09/2021
Event Type  malfunction  
Manufacturer Narrative
The sample was returned for evaluation. A follow-up report will be submitted once the investigation has been completed.
 
Event Description
During a breast biopsy when the radiologist remover the needle to extract the biopsy sample. The entire needle came out causing a needle stick to the radiologist.
 
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Brand NameACCUCORE SINGLE ACTION CORE BIOPSY DEVICE 14GA X 3 1/2"(9CM)
Type of DeviceACCUCORE
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
gina liu
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key12269222
MDR Text Key266841440
Report Number0001625425-2021-01052
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011270
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberR640914
Device Lot Number11344126
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/21/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/03/2021 Patient Sequence Number: 1
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