MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18GX10CM

Model Number	360-1080-01
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is indicated as available for evaluation.As of the date of this report, the device has not yet been returned.A follow-up report will be provided once more information is received and reviewed.
Event or Problem Description
Number of patient: 1.Position: prone.Lesion location:apical segment (s i) of right lung.Lesion size:= 1.0 cm.Technique: co-axial (mcxs1810bp).Result: incomplete sample (empty gun).Complication: parenchymal hemorrhage.
Event or Problem Description
Follow up.
Additional Manufacturer Narrative
H3 other text : placeholder.

• Brand Name: BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18GX10CM
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10515414
• Report Number: 1625425-2020-00516
• Device Sequence Number: 3552411
• Product Code: KNW
• UDI-Device Identifier: 00886333004379
• UDI-Public: 00886333004379
• 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): 09/10/2020

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: 09/10/2022
• Device Model Number: 360-1080-01
• Device Catalogue Number: 360-1080-01
• Device Lot Number: 11275526
• 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: 09/10/2020
• Supplement Report FDA Received Date: 10/14/2020
• 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