MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 16GA X 15CM

Model Number	370-1580-02
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Event or Problem Description
Biopsy instrument was unable to take a biopsy from tissue.Failed biopsy did lead to bleeding, not serious/life threatening.
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.
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.Seven unopened samples were returned by the customer.The visual inspection and testing was performed on sampling.The device was successful in taking the samples in all three stroke lengths thrice with no issue.No corrective action can be taken as the issue cannot be duplicated.
Event or Problem Description
Biopsy instrument was unable to take a biopsy from tissue.Failed biopsy did lead to bleeding, not serious/life threatening.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 16GA X 15CM
• 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: 16529694
• Report Number: 0001625425-2023-00997
• Device Sequence Number: 19472170
• Product Code: KNW
• UDI-Device Identifier: 00886333224081
• UDI-Public: 00886333224081
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2023
• Device Model Number: 370-1580-02
• Device Catalogue Number: 370-1580-02
• Device Lot Number: 11339623
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• 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; Other
• Patient Sex: Unknown