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

Model Number	370-1580-01
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2022
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
When the patient was performing liver puncture under the guidance of b-ultrasound, the biopsy needle was used.No tissue was taken from the puncture twice, only blood.Later, the puncture needle of other products was replaced successfully.The doctor believed that the condition prolonged the operation time and caused secondary injury to the patient, so he reported the incident to the competent authority.
Event or Problem Description
When the patient was performing liver puncture under the guidance of b-ultrasound, the biopsy needle was used.No tissue was taken from the puncture twice, only blood.Later, the puncture needle of other products was replaced successfully.The doctor believed that the condition prolonged the operation time and caused secondary injury to the patient, so he reported the incident to the competent authority.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.A used sample was returned to argon from the customer.A visual inspection was performed on the returned sample.The visual inspection established that the cannula tips are bent inward and the pincer was slightly flattened, preventing the device from properly obtaining a sample.There are stringent computer/photographic inspections that ensure the cannula tri-tips and the pincer are not deformed during the manufacturing process.Additionally, the exact conditions of the biopsy performed in the user environment is not known.If the device is fired into either very fatty or some sort of calcified tissue then it is possible for the needle set components to bend out of shape and the pincer to have a failure when collecting a sample and resulting in an incomplete or no sample defect.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 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: 15916614
• Report Number: 0001625425-2022-01153
• Device Sequence Number: 4348080
• Product Code: KNW
• UDI-Device Identifier: 20886333004366
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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: 01/11/2025
• Device Model Number: 370-1580-01
• Device Catalogue Number: 370-1580-01
• Device Lot Number: 11403053
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown