MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 10CM

Model Number	360-1080-02
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the sample is available.As of the date of this report, the sample has not been returned.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
When the shot is fired inside the patient to obtain the sample, the biopince is opened.Need for medical intervention to prevent injury or permanent disability.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.After three notifications, the sample from the alleged complaint has not returned.Additionally, no photographic or visual evidence was submitted that would have allowed this allegation to be reviewed.Without the necessary evidence, a thorough investigation cannot be performed.Determining a root cause and corrective action is not possible.No corrective action is required at this point.If the samples are returned at a later date, then this complaint may be reopened for re-evaluation.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 10CM
• Common Device Name: BIOPINCE
• 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: 20753991
• Report Number: 0001625425-2024-01149
• Device Sequence Number: 18457534
• Product Code: KNW
• UDI-Device Identifier: 00886333224005
• UDI-Public: (01)00886333224005(17)270717(10)11579541
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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: 360-1080-02
• Device Lot Number: 11579541
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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