MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18G X 15CM

Model Number	360-1580-01
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pneumothorax (2012)
Date of Event	07/30/2020
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: supine.Lesion location:anterior segment (s iii) of right lung.Lesion size:= 1.0 cm.Technique: co-axial (mcxs1815bp).Result: incomplete sample (empty gun).Complications: pneumothorax and bleeding.The doctor used 4 consecutive pieces of biopince (with the same lot number) for just one patient and failed to take the sample successfully.And the doctor finally gave up the operation because the patient was vomiting blood.
Event or Problem Description
Follow up.
Additional Manufacturer Narrative
H3 other text : placeholder.
Event or Problem Description
Follow up.

• Brand Name: BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18G X 15CM
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10515066
• Report Number: 1625425-2020-00515
• Device Sequence Number: 3507772
• Product Code: KNW
• UDI-Device Identifier: 00886333004355
• UDI-Public: 00886333004355
• 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,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: 12/18/2022
• Device Model Number: 360-1580-01
• Device Catalogue Number: 360-1580-01
• Device Lot Number: 11288752
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 10/14/2020; 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