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

Model Number	701118060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
Describe the event or problem: 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.Device malfunction - that is, the device did not do what it was supposed to do; device failed (e.G.Broke, couldn't get it to work or stopped working); device was hard to use;.
Additional Manufacturer Narrative
No sample was available for evaluation.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 actions that are being taken.

• 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 rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 17564607
• Report Number: 0001625425-2023-01159
• Device Sequence Number: 6862934
• Product Code: KNW
• UDI-Device Identifier: 00886333005963
• UDI-Public: 00886333005963
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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 Lot Number: 11461554
• Was Device Available for Evaluation?: No
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 08/29/2023
• 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
• 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