MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 16GA X 10CM

Model Number	370-1080-02
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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
The pincher is failing to retract back into the device once the biopsy has been taken.
Event or Problem Description
The pincher is failing to retract back into the device once the biopsy has been taken.
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.
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-conformances were found.One opened and five unopened samples were returned by the customer.A visual inspection could not find any damage with the biopince that was returned used and the pincer was in the proper location in the pincer window.Laboratory kidney biopsy testing was performed with the used biopince device and it was able to obtain 9 out of 9 samples with no defects.The exact conditions of the biopsy performed in the user environment is not known.If the device is fired into either very fatty tissue or some sort of hard tissue then it is possible for the pincer to have a failure when collecting a sample and resulting in an incomplete or no sample defect.There is no corrective action to take at this time as the issues described could not be replicated in the laboratory setting.Argon will continue to monitor the biopince ultra devices for the defects as described.
Event or Problem Description
The pincher is failing to retract back into the device once the biopsy has been taken.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 16GA X 10CM
• 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: 14069277
• Report Number: 0001625425-2022-00975
• Device Sequence Number: 20138523
• Product Code: KNW
• UDI-Device Identifier: 00886333224067
• UDI-Public: 00886333224067
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2024
• Device Model Number: 370-1080-02
• Device Catalogue Number: 370-1080-02
• Device Lot Number: 11391323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 03/29/2022; 03/29/2022
• Initial Report FDA Received Date: 04/10/2022
• Supplement Report FDA Received Date: 04/22/2022; 07/12/2022
• 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