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

Model Number	360-1580-01
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Insufficient Information (4580)
Date of Event	10/10/2022
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
Following several punctures , no samples retained.The patient must be repunctured several times in the liver.Hemorrhagic risk.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.Two sealed samples and one used sample was returned to argon for review.A visual inspection was performed on the returned samples.The visual inspection on the used sample established that the pincer of the used sample was flattened.This could prevent the device from taking samples properly.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.It is likely that these techniques were not performed.Not performing either of these techniques would make damage to the sensitive components of the needle extremely likely due to the toughness of tissue.The two sealed samples were functionally tested with a beef kidney.All three stroke lengths were fired on both devices and both devices took samples successfully.Since the two sealed devices took samples and since the damage to the used sample was most likely the result of am event within the user's environment, no corrective action will be performed.
Event or Problem Description
Following several punctures , no samples retained.The patient must be repunctured several times in the liver.Hemorrhagic risk.

• 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: 15812169
• Report Number: 0001625425-2022-01132
• Device Sequence Number: 5613396
• 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
• Report Date (Section B): 02/21/2023

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: 06/13/2025
• Device Model Number: 360-1580-01
• Device Catalogue Number: 360-1580-01
• Device Lot Number: 11426192
• 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: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• 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