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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18G X 15CM
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ARGON MEDICAL DEVICES BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18G X 15CM Back to Search Results
Model Number 360-1580-01
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for evaluation.A follow-up report will be submitted once the sample has been received and reviewed.
 
Event or Problem Description
The needle was broken inside, the needle was left in the device when triggered it.It is very dangerous.The event was found after it was used on the patient, but it did not break off inside the patient.
 
Additional Manufacturer Narrative
H3 other text: placeholder.
 
Event or Problem Description
Follow up.
 
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Brand Name
BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18G X 15CM
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
MDR Report Key11310947
Report Number1625425-2021-00844
Device Sequence Number11410511
Product Code KNW
UDI-Device Identifier00886333004355
UDI-Public00886333004355
Combination Product (Y/N)N
PMA/510(K) Number
K904987
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date (Section B) 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date12/21/2022
Device Model Number360-1580-01
Device Catalogue Number360-1580-01
Device Lot Number11289335
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date02/10/2021
Supplement Report FDA Received Date02/25/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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