MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE

Model Number	701218200
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2022
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
Needle inserted into patient.Broke apart upon firing to retrieve sample.
Additional Manufacturer Narrative
The sample is indicated as available for return and has not been returned to the manufacturer yet.Customer confirmed that the event occurred prior use in patient and during pre-test making this event not mdr reportable anymore.If more information is available after sample investigation a follow-up report will be submitted.
Event or Problem Description
The needle broke apart when test-fired before using in patient.The procedure was completed with a new argon needle.

• Brand Name: SUPERCORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE
• Common Device Name: SUPERCORE
• 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: 15313973
• Report Number: 0001625425-2022-01079
• Device Sequence Number: 20213191
• Product Code: KNW
• UDI-Device Identifier: 00886333006052
• UDI-Public: 00886333006052
• Combination Product (Y/N): N
• 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: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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
• Device Model Number: 701218200
• Device Catalogue Number: 701218200
• Device Lot Number: 11410002
• Was Device Available for Evaluation?: Yes
• 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: 08/15/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1625425-09/30/2021-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown