MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT

Model Number	701118090
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned to argon for evaluation.As of the date of this report, the sample has not yet been received.A follow-up report will provided once the sample has been returned and reviewed.
Event or Problem Description
The procedure was an ultrasound biopsy, a co-axial 3.9cm introducer was inserted under anaesthetic and then the biopsy device passed through the middle.This encountered a lot of resistance, although the patient did not flinch at this.A scanty tissue specimen was recovered and then the biopsy needle was re- positioned and placed into the introducer.On the second pass dr.Taylor experienced resistance both on firing the needle and withdrawing this through the introducer.A good tissue sample was delivered, but also a v- shaped silver of metal which appeared to have been sheared off the specimen notch.A second identical needle was therefore used to complete the procedure without any further problems.
Event or Problem Description
Follow up.
Additional Manufacturer Narrative
H3 other text : placeholder.

• Brand Name: SUPERCORE BIOPSY INSTRUMENT
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10286863
• Report Number: 1625425-2020-00412
• Device Sequence Number: 516260
• Product Code: KNW
• UDI-Device Identifier: 00886333005895
• UDI-Public: 00886333005895
• Combination Product (Y/N): N
• PMA/510(K) Number: K974814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2020

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 Expiration Date: 07/09/2023
• Device Model Number: 701118090
• Device Catalogue Number: 701118090
• Device Lot Number: 11225132
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1