MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE FULL CORE BIOPSY INSTRUMENT 16G X 10CM

Model Number	370-1080-01
Medical Device Problem Codes	Failure to Obtain Sample (2533); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	09/20/2023
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
The surgeon used the needle for the first core biopsy specimen.The patient experienced a lot of pain and discomfort.Upon obtaining the first specimen he examined the needle and saw it was bent.He then changed to another needle, the same type and size.Two more specimens were obtained.The patient did not experienced pain and discomfort with the 2nd needle.
Event or Problem Description
Dr the surgeon used the needle for the first core biopsy specimen.The patient experienced a lot of pain and discomfort.Upon obtaining the first specimen he examined the needle and saw it was bent.He then changed to another needle, the same type and size.Two more specimens were obtained.The patient did not experienced pain and discomfort with the 2nd needle.
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 products, and it was found that the tri-tips were bent out of shape, preventing the device from properly obtaining a sample, hence the complaint was confirmed.There are stringent computer and photographic inspections that ensure the cannula tri-tips are not deformed during the manufacturing process.The tri-tip damage was likely caused by the device striking a hard external surface or a hard object such as a bone or possibly getting caught on some human tissue and pulling back.Since the most likely cause for the damaged needles is related to an event within the user's environment and not a manufacturing issue, no corrective action can be implemented at this time.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 16G X 10CM
• Common Device Name: BIOPINCE
• 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: 17941841
• Report Number: 0001417485-2023-00006
• Device Sequence Number: 2983459
• Product Code: KNW
• UDI-Device Identifier: 00886333004386
• UDI-Public: (01)00886333004386(17)250817(10)11436037
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K904987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2024

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 Expiration Date: 08/17/2025
• Device Model Number: 370-1080-01
• Device Lot Number: 11436037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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; 09/04/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 01/11/2024; 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown