MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 20CM

Model Number	360-2080-01
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
¿biopince loaded normally and triggered as a test during the "shot" test.Nothing noticeable.Then during the liver biopsy (needle in the patient), the "shot" cannot be fired.Withdrawal and new biopince with problem-free biopsy.When you then try again to fire the shot (not on the patient), this succeeds without any problems.Then you notice that the tip is not pointed but jagged like a crown.Wasn't the case with the first test attempt outside of the patient.In this case it was perfect that the shot could not be fired when the needle was in the patient.Outside the patient, however, the shot could be fired without any problems, despite this defect.
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.The customer did not return any samples for evaluation.But photographs were provided which were unclear to apprehend.Without the actual sample the investigation cannot be performed.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 FULL CORE BIOPSY INSTRUMENT 18G X 20CM
• 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: 17209399
• Report Number: 0001625425-2023-01109
• Device Sequence Number: 17563803
• Product Code: KNW
• UDI-Device Identifier: 00886333004348
• UDI-Public: 00886333004348
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2023

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: 09/13/2025
• Device Model Number: 360-2080-01
• Device Catalogue Number: 360-2080-01
• Device Lot Number: 11439746
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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