MAUDE Adverse Event Report: ARGON MEDICAL DEVICES TRU-CORE II BIOPSY INSTRUMENT 16GA X 10CM

Model Number	763116100X
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
Event or Problem Description
The device was used for breast biopsy.At the 3rd biopsy with the device, the device was not able to remove from the patient after firing due to strong resistance.The physician attempted to remove the stuck needle by rotating and pushing forward/backward the device and then finally able to be pulled out.There was a risk to cause extra bleeding.The device was switched to another new one to complete the biopsy.Sugan comment upon check of the returned product; the device was able to set in ready position, however, an abnormality was confirmed at the setting motion.When knob 1 was being pulled down, knob 2 also moved along with knob 1.
Event or Problem Description
The device was used for breast biopsy.At the 3rd biopsy with the device, the device was not able to remove from the patient after firing due to storong resistance.The physician attempted to remove the stuck needle by rotating and pushing forward/backward the device and then finally able to be pulled out.There was a risk to cause extra bleeding.The device was switched to another new one to complete the biopsy.Sugan comment upon check of the returned product; the device was able to set in ready position, however, an abnormality was confirmed at the setting motion.When knob 1 was being pulled down, knob 2 also moved along with knob 1.
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 opened device was returned for evaluation.Visual inspection found no damage to the device.The device was test fired five times and functioned as designed.Further inspection found that the device handle, proximal, and distal ends of the needle set were full of dried organic matter, which could cause loading and firing issues due to adhering the stylet to the cannula, if the device was not rinsed in between uses.This would explain the result that the distributor found before returning the device to argon.As no defects were found with the device, and it functioned as designed when it was tested at argon, no corrective actions were taken.

• Brand Name: TRU-CORE II BIOPSY INSTRUMENT 16GA X 10CM
• 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: 16630993
• Report Number: 0001625425-2023-01012
• Device Sequence Number: 5577240
• Product Code: KNW
• UDI-Device Identifier: 00886333006618
• UDI-Public: 00886333006618
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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: 763116100X
• Device Catalogue Number: 763116100X
• Device Lot Number: 11452416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown