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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 16G X 15CM
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ARGON MEDICAL DEVICES BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 16G X 15CM Back to Search Results
Model Number 370-1580-01
Health Effect - Clinical Codes Hemorrhage/Blood Loss/Bleeding (1888); Injury (2348)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device used is scheduled to be returned for evaluation.A follow-up report will be provided once the device has been received and reviewed.
 
Event or Problem Description
During withdraw of the devices the liver has been hurt because of a distant metal splint.The patient has suffered a bleeding of the liver the patient is stable at the moment.No medical intervention was necessary.The procedure could not be completed successfully.
 
Event or Problem Description
Follow up.
 
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Brand Name
BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 16G X 15CM
Common Device Name
BIOPINCE
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
MDR Report Key10376905
Report Number1625425-2020-00471
Device Sequence Number11485474
Product Code KNW
UDI-Device Identifier00886333004362
UDI-Public00886333004362
Combination Product (Y/N)N
PMA/510(K) Number
K904987
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date (Section B) 08/06/2020
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 Date01/24/2023
Device Model Number370-1580-01
Device Catalogue Number370-1580-01
Device Lot Number11292772
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date08/06/2020
Supplement Report FDA Received Date08/19/2020
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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