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

Model Number	701218150
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
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 came out during the procedure.
Event or Problem Description
Needle came out during the procedure.
Additional Manufacturer Narrative
A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.One opened device was returned for evaluation.Visual inspection found that the body of the device was split proximally, with the spring released, and the complaint was confirmed.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.

• Brand Name: SUPERCORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE
• Common Device Name: SUPERCORE BIOPSY
• 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: 13334135
• Report Number: 0001625425-2022-00938
• Device Sequence Number: 14778084
• Product Code: KNW
• UDI-Device Identifier: 00886333005987
• UDI-Public: 00886333005987
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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 Model Number: 701218150
• Device Catalogue Number: 701218150
• Device Lot Number: 11397101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• 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: 01/16/2022
• Supplement Date Received by Manufacturer: 01/16/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 02/28/2022
• 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
• Usage of Device: Initial
• 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