MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18GX10CM

Model Number	360-1080-01
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.Argon will continue to request its return.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
The device was functional in its firing mechanism however did not pull a core of the liver tissue the physician attempted twice and with no result opted to open a new device as to not put the patient at increased risk for bleeding.
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.Argon will continue to request its return.A follow-up report will be provided once the device has been received and reviewed.H3 other text: placeholder.
Event or Problem Description
The device was functional in its firing mechanism however did not pull a core of the liver tissue the physician attempted twice and with no result opted to open a new device as to not put the patient at increased risk for bleeding.
Additional Manufacturer Narrative
H3 other text: placeholder.
Event or Problem Description
Follow up.

• Brand Name: BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18GX10CM
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 11040344
• Report Number: 1625425-2020-00794
• Device Sequence Number: 2610726
• Product Code: KNW
• UDI-Device Identifier: 00886333004379
• UDI-Public: 00886333004379
• Combination Product (Y/N): N
• Initial Reporter State: UT
• PMA/510(K) Number: K904987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2020

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: 10/08/2023
• Device Model Number: 360-1080-01
• Device Catalogue Number: 360-1080-01
• Device Lot Number: 11331874
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 01/22/2021; 01/27/2021
• 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