MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT 18GA X 15CM

Model Number	701118150
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem 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.".
Additional Manufacturer Narrative
The sample is indicated as returned to argon for investigation.A follow-up report will be submitted upon investigation completion.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.One opened sample was returned from the customer for review.A visual inspection was performed on the returned product.It was found that the plunger came off, inhibiting the device to function as intended.The complaint was confirmed.A sustaining engineering project has been initiated to investigate the issue in detail and identify the root cause and implement the corrective action to address the issue.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: SUPERCORE BIOPSY INSTRUMENT 18GA X 15CM
• Common Device Name: 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 Key: 19185954
• Report Number: 0001625425-2024-00996
• Device Sequence Number: 7147553
• Product Code: KNW
• UDI-Device Identifier: 00886333005888
• UDI-Public: (01)00886333005888(17)281113(10)11506806
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2024

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
• Operator of Device: Health Professional
• Device Model Number: 701118150
• Device Lot Number: 11506806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 06/03/2024; 08/31/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 07/02/2024; 08/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown