MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT 18GA X 9CM

Model Number	701118090
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/08/2021
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
The supercore needle fell apart during use.The doctor stabbed his hand with the broken device, left hand, little finger.No injury to patient.
Additional Manufacturer Narrative
One opened device was returned for evaluation.Visual inspection found that the stylet was separated from the body of the device, with signs of the body having split open proximally.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 initiated to document our investigation into the cause of this problem and the corrective action that are being taken to prevent the re-occurrence of this problem.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
The supercore needle fell apart during use.The doctor stabbed his hand with the broken device, left hand, little finger.No injury to patient.

• Brand Name: SUPERCORE BIOPSY INSTRUMENT 18GA X 9CM
• Common Device Name: SUPERCORE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: gedaa hassan ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 12661472
• Report Number: 0001625425-2021-01103
• Device Sequence Number: 11975020
• Product Code: KNW
• UDI-Device Identifier: 00886333005895
• UDI-Public: 00886333005895
• 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): 11/10/2021

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: 05/21/2026
• Device Model Number: 701118090
• Device Catalogue Number: 701118090
• Device Lot Number: 11367439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• 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: 10/08/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/10/2021
• 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
• 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