MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE FULL CORE BIOPSY INSTRUMENT 16G X 15CM; BIOPINCE BIOPSY

Model Number	370-1580-01
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for evaluation.A follow-up report will be submitted once the sample has been received and reviewed.
Event or Problem Description
Biopince: 16gx15cm was used for lung biopsy and the device didn¿t fetch any sample even after multiple firing.Doctor used bard biopsy gun and it fetched sample.
Additional Manufacturer Narrative
H3 other text: placeholder.
Event or Problem Description
Follow up.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 16G X 15CM
• Common Device Name: BIOPINCE BIOPSY
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 11340862
• Report Number: 1625425-2021-00852
• Device Sequence Number: 11802894
• Product Code: KNW
• UDI-Device Identifier: 00886333004362
• UDI-Public: 00886333004362
• Combination Product (Y/N): N
• PMA/510(K) Number: K904987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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 Expiration Date: 10/01/2023
• Device Model Number: 370-1580-01
• Device Catalogue Number: 370-1580-01
• Device Lot Number: 11330456
• 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: 02/17/2021
• Supplement Report FDA Received Date: 03/17/2021
• 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