MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 10CM

Model Number	360-1080-02
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
We've had two that did not produce a "sample".One was about a month ago on a kidney biopsy (with dr.H), the other was yesterday on a breast biopsy (with dr.S).I would assume they came from different lots (we go through at least 5 times the needles at (b)(6)).Dr.H tried 2 biopsies with the needle before switching to another, as did dr.S.There was absolutely no tissue sample in the chamber.Kidneys are very vascular (bleed easliy).So we typically take only 2-3 biopsies.This patient had to have a total of 5 which is unacceptable.
Additional Manufacturer Narrative
Sample is unavailable for evaluation.Without such evident to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 10CM
• Common Device Name: BIOPINCE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 14305080
• Report Number: 0001625425-2022-01003
• Device Sequence Number: 17447894
• Product Code: KNW
• UDI-Device Identifier: 00886333224005
• UDI-Public: 00886333224005
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K904987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 360-1080-02
• Device Catalogue Number: 360-1080-02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown