MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE

Model Number	701218090
Medical Device Problem Codes	Failure to Fire (2610); Firing Problem (4011)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
When resetting the biopsy needle, the handle failed at the spring, making it impossible to reengage the needle to perform a second biopsy.Increased duration of the procedure / pain for the patient.
Additional Manufacturer Narrative
Sample is indicated as returned.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
When resetting the biopsy needle, the handle failed at the spring, making it impossible to reengage the needle to perform a second biopsy.Increased duration of the procedure / pain for the patient.
Additional Manufacturer Narrative
After performing a search of our complaint database for reports of similar conditions it has been determined that the noncompliance reported has been experienced by other customers as well.Since the production of lot 11416767 corrective actions have been implemented per capa c-2021-061.
Event or Problem Description
When resetting the biopsy needle, the handle failed at the spring, making it impossible to reengage the needle to perform a second biopsy.Increased duration of the procedure/pain for the patient.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: SUPERCORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE
• Common Device Name: SUPERCORE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 17949270
• Report Number: 0001417485-2023-00007
• Device Sequence Number: 6790530
• Product Code: KNW
• UDI-Device Identifier: 00886333006045
• UDI-Public: (01)00886333006045(17)270411(10)11416767
• 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
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,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: 701218090
• Device Lot Number: 11416767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: 10/06/2023; 10/06/2023; 08/31/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/29/2023; 01/20/2024; 08/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1625425-09/30/2021-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown