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

Model Number	370-1580-01
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is indicated as returned.As of the date of this report, sample has not been evaluated.A follow-up report will be submitted once the sample has been reviewed.
Event or Problem Description
Empty sample.No sample when the biotweezer is removed.Difficulty removing the bioweezer from the coaxial sheath.Need to repeat a new biopsy increasing the risk of bleeding.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.One used sample was returned to argon from the customer.A visual inspection was performed on the returned product.The visual inspection established that the pincer was flattened and bent inward onto itself.According to the per form, no accessory device was used, and there was no mention of an incisional dermatotomy prior to activating the device through the skin as the ifu instructs.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.There are stringent computer/photographic inspections that ensure the pincer is not deformed during the manufacturing process and has the proper radius.Since the most likely cause for the damaged pincer 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
Empty sample.No sample when the biotweezer is removed.Difficulty removing the bioweezer from the coaxial sheath.Need to repeat a new biopsy increasing the risk of bleeding.

• 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: 15812137
• Report Number: 0001625425-2022-01131
• Device Sequence Number: 17524948
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

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
• 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
• Date Returned to Manufacturer: 11/14/2022
• 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: 11/04/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• 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