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

Model Number	370-1080-01
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for evaluation.As of the date of this report, it has not yet been returned.A follow-up report will be provided once the sample has been received and reviewed.
Event or Problem Description
Physician reports that during procedure 3 units of the device, they do not take specimen and in one of the units, the receding of the tab that holds the sample is observed, which is a risk of tearing for the patient.It was a failure when patient was punctured with the needle and no sample was captured.No damage occurred.
Event or Problem Description
Follow up.
Additional Manufacturer Narrative
H3 other text: placeholder.

• Brand Name: BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 16G X 10CM
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 11276604
• Report Number: 1625425-2021-00840
• Device Sequence Number: 3120773
• Product Code: KNW
• UDI-Device Identifier: 00886333004386
• UDI-Public: 00886333004386
• Combination Product (Y/N): N
• PMA/510(K) Number: K904987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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: 04/27/2023
• Device Model Number: 370-1080-01
• Device Catalogue Number: 370-1080-01
• Device Lot Number: 11307817
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other