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

Model Number	763116160X
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
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 observed that the needle stylet was damaged.The complaint was confirmed.The damage of the needle set prevented from further investigation.The area supervisor has been notified about the issue to monitor the reoccurrence as this was an issue in isolation.
Event or Problem Description
In an elective kidney biopsy with a biopsy instrument, the following incident can be reported today, the tensioned biopsy needle was inserted into the patient.After activating the trigger mechanism, the device fired a "shot" as intended.When pulling it out, however, the shield above the needle was open and the device could not be tensioned again.The biopsy cylinder was lost, so the patient was unnecessarily subjected to a increased risk because it had to be biopsied again.

• Brand Name: TRU-CORE II BIOPSY INSTRUMENT 16GA X 16CM
• Common Device Name: TRU-CORE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 19662648
• Report Number: 0001625425-2024-01056
• Device Sequence Number: 6847982
• Product Code: KNW
• UDI-Device Identifier: 00886333006601
• UDI-Public: (01)00886333006601(17)281023(10)11504000
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 763116160X
• Device Lot Number: 11504000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown