MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 15CM

Model Number	360-1580-01
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
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
Perform renal biopsy on the patient, cut the kidney tissue 4 times, the biopsy needle can only take out a very small amount of tissue; this incident was not used with a coaxial guide needle, the gun was not tested before use, and the instrument was taken out without 360-degree rotation.The firing range is 23mm, and the empty gun occurs in the 1st shot.
Event or Problem Description
Perform renal biopsy on the patient, cut the kidney tissue 4 times, the biopsy needle can only take out a very small amount of tissue; this incident was not used with a coaxial guide needle, the gun was not tested before use, and the instrument was taken out without 360-degree rotation.The firing range is 23mm, and the empty gun occurs in the 1st shot.
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.
Event or Problem Description
Perform renal biopsy on the patient, cut the kidney tissue 4 times, the biopsy needle can only take out a very small amount of tissue; this incident was not used with a coaxial guide needle, the gun was not tested before use, and the instrument was taken out without 360-degree rotation.The firing range is 23mm, and the empty gun occurs in the 1st shot.
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-conformance's were found relating to this issue.One opened sample was returned by the customer.A visual inspection found that the needle set was badly bent and the pincer had been folded into an arch shape.Additionally, it was found that the needle set had broken out of the clump and the carriage.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.Once flattened, the pincer can strike the pincer window and be forced to fold upward, resulting in the arch shape observed in this unit.The needle set bending and broken clump and carriage is likely a result of misuse in the user environment and excessive force being enacted on the device.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.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G 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: 14407178
• Report Number: 0001625425-2022-01006
• Device Sequence Number: 5564326
• Product Code: KNW
• UDI-Device Identifier: 00886333004355
• UDI-Public: 00886333004355
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2022

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
• Device Expiration Date: 08/19/2022
• Device Model Number: 360-1580-01
• Device Catalogue Number: 360-1580-01
• Device Lot Number: 11272997
• 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: 05/16/2022
• Supplement Date Received by Manufacturer: 05/11/2022; 05/11/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 07/11/2022; 08/15/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown