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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 15CM
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ARGON MEDICAL DEVICES BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 15CM Back to Search Results
Model Number 360-1580-01
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2024
Event Type  malfunction  
Event Description
The reporter indicated the biopsy needle's outer sheath fell off, and the needle almost penetrated the heart.It was reported there was no patient injury.
 
Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
 
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Brand Name
BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 15CM
Type of Device
BIOPINCE FULL CORE BIOPSY INSTRUMENT
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
kelly mayer
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key19199143
MDR Text Key341999898
Report Number0001625425-2024-01004
Device Sequence Number1
Product Code KNW
UDI-Device Identifier00886333004355
UDI-Public00886333004355
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K904987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number360-1580-01
Device Lot Number11469029
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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