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

Model Number	360-1080-01
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two sealed samples and two opened samples were returned for review.The two sealed samples were opened and test fired five times each with no issues observed.The pincer fired into the window as designed.The two opened samples exhibited signs of use with the presence of dried bodily fluids present on the needle and on the housing of both returned devices.The pincer of each device was observed to be damaged which would prevent the device from taking a sample successfully, confirming the complaint.Capa 1027 was initiated to evaluate biopince occurrences where a tissue sample was not retrieved.As part of the investigation, there were two potential root causes identified: the tolerance on the inner diameter of the coaxial introducer needle possibly interferes with the hump of the pincer when the device is in the cocked condition.The pincer cannula not diving into the cutting cannula window.To address the issue, the following corrective actions were implemented: the pincer was realigned to bring the pincer tip closer to the cutting cannula window.This realignment allows the pincer to more reliably dive into the window during use.The design of the coaxial needle introducers was changed to increase the inner diameter.Design verification was conducted for the coaxial introducers with larger inner diameters.The larger inner diameter allows for no possible tolerance interference between the biopince device and the coaxial introducer needle.
Event or Problem Description
Dr.(b)(6) did a liver bx and used two biopsy guns where no sample was obtained (just blood).He had to use a third needle with a different lot number and finally got specimen.So instead of the usual 2-3 passes, he ended up doing 7 passes in a transplant liver to get enough cores to send to path.Another physician had issues with it this weekend as well and according to the other physicians this has happened to them in the past.

• Brand Name: BIOPINCE AUTOMATIC FULL CORE BIOPSY INSTRUMENT 18GX10CM
• Common Device Name: BIOPINCE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10950930
• Report Number: 1625425-2020-00744
• Device Sequence Number: 4329883
• Product Code: KNW
• UDI-Device Identifier: 00886333004379
• UDI-Public: 00886333004379
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2020

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: 10/08/2023
• Device Model Number: 360-1080-01
• Device Catalogue Number: 360-1080-01
• Device Lot Number: 11331874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2020
• 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