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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT 18GA X 15CM
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ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT 18GA X 15CM Back to Search Results
Model Number 701118150
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2024
Event Type  malfunction  
Event Description
A reporter indicated "came away in the patient mid procedure after firing the needle.We manage to remove the core and then used another needle to take more samples.There was no harm to the patient.".
 
Manufacturer Narrative
The sample is indicated as returned to argon for investigation.A follow-up report will be submitted upon investigation completion.
 
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Brand Name
SUPERCORE BIOPSY INSTRUMENT 18GA X 15CM
Type of Device
SUPERCORE BIOPSY
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 Key19185954
MDR Text Key341625127
Report Number0001625425-2024-00996
Device Sequence Number1
Product Code KNW
UDI-Device Identifier00886333005888
UDI-Public00886333005888
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K974814
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 04/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number701118150
Device Lot Number11506806
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/26/2024
Initial Date FDA Received04/25/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/27/2023
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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