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

Model Number	360-1580-01
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The needle of the biopsy needle was deformed, and it was stuck in the body after firing and could not be taken out.Finally, it was taken out together with the co-axial introducer needles, causing the patient to bleed.
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.
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
The needle of the biopsy needle was deformed, and it was stuck in the body after firing and could not be taken out.Finally, it was taken out together with the co-axial introducer needles, causing the patient to bleed.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.One opened sample was returned from the customer for review.A visual inspection was performed on the returned product.The visual inspection established that the cannula tips, pincer, and needle set were bent.This could cause the device to not take samples properly.It is possible that excessive force was applied at an angle during manipulation of the device causing damage to the needle set and cannula tips.Since the cause of the damage is most likely a result of an event within the user's environment, no corrective action will be implemented.
Event or Problem Description
The needle of the biopsy needle was deformed, and it was stuck in the body after firing and could not be taken out.Finally, it was taken out together with the co-axial introducer needles, causing the patient to bleed.

• 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: 13266118
• Report Number: 0001625425-2022-00929
• Device Sequence Number: 20015306
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2023
• Device Model Number: 360-1580-01
• Device Catalogue Number: 360-1580-01
• Device Lot Number: 11331209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• 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: 01/13/2022
• Supplement Date Received by Manufacturer: 01/13/2022; 01/13/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 02/28/2022; 03/15/2022
• 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: Required Intervention; Other
• Patient Sex: Unknown