MAUDE Adverse Event Report: ARGON MEDICAL DEVICES TRU-CORE II BIOPSY INSTRUMENT 20GA X 16CM

Model Number	763120160X
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2022
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
The tip of the needle is damaged and the tissue cannot be removed.
Additional Manufacturer Narrative
A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.One device was returned for evaluation.Visual inspection found no damage to the device or the needle set.The device was test fired five times.Knob one would lock.Knob two would not lock and the complaint was confirmed.This device was manufactured before the corrective actions of capa 19-001.Therefore, no further evaluation is needed.
Event or Problem Description
The tip of the needle is damaged and the tissue cannot be removed.

• Brand Name: TRU-CORE II BIOPSY INSTRUMENT 20GA X 16CM
• Common Device Name: TRU-CORE
• 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: 15075838
• Report Number: 0001625425-2022-01043
• Device Sequence Number: 4668136
• Product Code: KNW
• UDI-Device Identifier: 00886333006571
• UDI-Public: 00886333006571
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K982960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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 Expiration Date: 12/20/2024
• Device Model Number: 763120160X
• Device Catalogue Number: 763120160X
• Device Lot Number: 11288591
• 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: 07/11/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown