MAUDE Adverse Event Report: ARGON MEDICAL DEVICES TLAB TRANSJUGULAR LIVER BIOPSY SYSTEM; TLAB BIOPSY

Model Number	TL-18C
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample was returned for evaluation.The investigation is in progress and a follow-up report will be submitted once it has been completed.
Event or Problem Description
Tlab transjugular liver biopsy system can normally got fired but couldn't get a tissue sample.
Additional Manufacturer Narrative
H3 other text: placeholder.
Event or Problem Description
Follow up.
Additional Manufacturer Narrative
H3 other text: placeholder.
Event or Problem Description
Follow up.

• Brand Name: TLAB TRANSJUGULAR LIVER BIOPSY SYSTEM
• Common Device Name: TLAB BIOPSY
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 11376730
• Report Number: 1625425-2021-00854
• Device Sequence Number: 16885344
• Product Code: DYB
• UDI-Device Identifier: 00886333218509
• UDI-Public: 00886333218509
• Combination Product (Y/N): N
• PMA/510(K) Number: K022634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2021

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 Model Number: TL-18C
• Device Catalogue Number: TL-18C
• Device Lot Number: NO28
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/24/2021; 04/29/2021
• 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