MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT

Model Number	360-1580-03
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is not available for return.Images were provided for investigation.A follow-up report will be submitted once the image has been reviewed.
Event or Problem Description
The shank of the needle is very stiff.And when taking the sample the needle came out like a carving knife, which caused more than normal bleeding in the patient.
Additional Manufacturer Narrative
A review of the dhrs of the top level and sublots as well as the inspection records was conducted, and no deviations or non-conformances were found relating to this issue.No products were returned from the customer however an image was provided.A visual inspection was performed on the photographs provided by the customer, and it was found that the tri-tips were bent out of shape, preventing the device from properly obtaining a sample, hence the complaint is 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.
Event or Problem Description
The shank of the needle is very stiff.And when taking the sample the needle came out like a carving knife, which caused more than normal bleeding in the patient.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
• 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: 16233394
• Report Number: 0001625425-2023-00943
• Device Sequence Number: 6992622
• Product Code: KNW
• UDI-Device Identifier: 00886333224036
• UDI-Public: 00886333224036
• 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
• Report Date (Section B): 05/23/2023

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 Expiration Date: 02/11/2025
• Device Model Number: 360-1580-03
• Device Catalogue Number: 360-1580-03
• Device Lot Number: 11407777
• Was Device Available for Evaluation?: No
• 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: 01/16/2023
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2022
• 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