MAUDE Adverse Event Report: ARGON MEDICAL DEVICES TRU-CORE II BIOPSY INSTRUMENT

Model Number	763116100X
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is indicated as unavailable for evaluation.Without the device or any visual evidence to review, the complaint cannot be confirmed and the root cause cannot be determined.If additional information is provided in the future, the investigation will be re-evaluated as needed and a follow-up report will be provided.
Event or Problem Description
It cannot lock during procedure and one more pic cannot take the sample after shooting into the patient tissue.

• Brand Name: TRU-CORE II BIOPSY INSTRUMENT
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10171541
• Report Number: 1625425-2020-00358
• Device Sequence Number: 19685163
• Product Code: KNW
• UDI-Device Identifier: 00886333006618
• UDI-Public: 00886333006618
• Combination Product (Y/N): N
• PMA/510(K) Number: K982960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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: 06/20/2023
• Device Model Number: 763116100X
• Device Catalogue Number: 763116100X
• Device Lot Number: 11222640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other