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

Model Number	370-1580-01
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The tissue could not be taken out; this incident was used with a coaxial guide needle.The gun was not tested before use.When the instrument was taken out, it was rotated 360 degrees.The range of use was 23mm.The empty gun occurred at the first needle.
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.One opened sample was returned from the customer for review.A visual inspection was performed on the returned product and it was found that the pincer was flattened, inhibiting it from properly obtaining a sample.There are stringent computer/photographic inspections that ensure the pincer is not deformed during the manufacturing process and has the proper radius.When the device is cocked, the pincer comes out of its window and becomes exposed to the tissues and structures present during the operation.Without the use of a proper sized coaxial needle, such as the inner diameter being too small, the pincer can be pushed flat.It is also possible that the needle set was inserted into tissue that was too hard for the sensitive pincer, pushing it flat.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 tissue could not be taken out; this incident was used with a coaxial guide needle.The gun was not tested before use.When the instrument was taken out, it was rotated 360 degrees.The range of use was 23mm.The empty gun occurred at the first needle.
Event or Problem Description
The tissue could not be taken out; this incident was used with a coaxial guide needle.The gun was not tested before use.When the instrument was taken out, it was rotated 360 degrees.The range of use was 23mm.The empty gun occurred at the first needle.
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 16G 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: 14643373
• Report Number: 0001625425-2022-01017
• Device Sequence Number: 5195589
• Product Code: KNW
• UDI-Device Identifier: 00886333004362
• UDI-Public: 00886333004362
• 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: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2022

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
• Device Expiration Date: 05/17/2024
• Device Model Number: 370-1580-01
• Device Catalogue Number: 370-1580-01
• Device Lot Number: 11368354
• 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: 05/30/2022
• Supplement Date Received by Manufacturer: 05/30/2022; 05/30/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 07/11/2022; 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1625425-12/3/2019-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown