MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT 18GA X 6CM

Model Number	701118060
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, and evaluation is anticipated but had not yet begun.A follow-up report will be submitted once the device has been evaluated.
Event or Problem Description
Swelling in biopsy area.Update/per the ultrasound tech- as the dr.Inserted the needle and pressed the button the coil popped out which caused swelling in the area the needle was at.
Event or Problem Description
Swelling in biopsy area.
Additional Manufacturer Narrative
The device was returned, and evaluation is anticipated but had not yet begun.A follow-up report will be submitted once the device has been evaluated.
Additional Manufacturer Narrative
Eight unopened devices were returned for evaluation.Visual inspection found no damage to the devices.The devices were tested fired five times each and two of the devices came apart proximally.Thereby confirming the complaint.Argon medical devices has received other complaints that the supercore semi-automatic biopsy instrument is coming apart during or prior to use.Argon has conducted an internal investigation and tracked the affected parts to a narrow time frame resulting from a specific manufacturing event.The plastic housing and plunger can be separated more easily than normal for the lots manufactured during this time frame.Capa 2021-061 has been opened to document our investigation into the cause of this problem and the corrective action that are being taken to ensure that this never happens again.To ensure continued customer satisfaction, argon medical devices has decided to issue a voluntary recall of the affected lots because of the high rate of reports of unintentional disassembly of these devices.
Event or Problem Description
Swelling in biopsy area.

• Brand Name: SUPERCORE BIOPSY INSTRUMENT 18GA X 6CM
• Common Device Name: SUPERCORE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 12715783
• Report Number: 0001625425-2021-01112
• Device Sequence Number: 1361976
• Product Code: KNW
• UDI-Device Identifier: 00886333005963
• UDI-Public: 00886333005963
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K974814
• 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): 11/22/2021

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: 06/05/2026
• Device Model Number: 701118060
• Device Catalogue Number: 701118060
• Device Lot Number: 11371012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• 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: 10/12/2021
• Supplement Date Received by Manufacturer: 10/12/2021; 11/22/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 11/17/2021; 12/02/2021
• 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: Other
• Patient Sex: Unknown