MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. SUPERCORE¿ BIOPSY INSTRUMENT; INSTRUMENT, BIOPSY

Model Number	701118060
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The radiologist was doing a procedure on the patient's left shoulder.When she pulled the device from the patient after taking a pass containing a specimen the device disassembled falling apart in the radiologist hands.She was almost punctured with the blade from the device.

• Brand Name: SUPERCORE¿ BIOPSY INSTRUMENT
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 17396427
• Report Number: 17396427
• Device Sequence Number: 6054552
• Product Code: KNW
• UDI-Device Identifier: 00886333005963
• UDI-Public: (01)00886333005963
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/09/2023
• Report Date (Section F): 05/09/2023

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: 701118060
• Device Catalogue Number: 701118060
• Device Lot Number: 11461554
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/09/2023