MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT

Model Number	370-1080-03
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Dr (b)(6) reached out again regarding the quality of bpu.He expressed complaints again regarding the throw length adjuster moving from desired length.He did not use a co-axial.The device was set to the 23mm length and fired at the 33mm length.This happened with one device which will be sent back, they had an additional 25 units on the shelf and requested that i send them all back to quality.
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
Dr.(b)(6) reached out again regarding the quality of bpu.He expressed complaints again regarding the throw length adjuster moving from desired length.He did not use a co-axial.The device was set to the 23mm length and fired at the 33mm length.This happened with one device which will be sent back, they had an additional 25 units on the shelf and requested that i send them all back to quality.
Additional Manufacturer Narrative
A review of the dhrs of the top level and sublots as well as the inspection records was conducted, and no deviations or non-conformances were found relating to this issue.Twenty seven unopened sample was returned from the customer for review.A visual inspection was performed on five of the returned product.The device worked perfectly fine without any automatic change in stroke length adjuster when test fired on all three stroke lengths.This happens only when the devices stroke length adjuster is not perfectly aligned at its mark.No corrective action can be taken at this time since issue cannot be duplicated.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
• 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: 16963987
• Report Number: 0001625425-2023-01060
• Device Sequence Number: 14762105
• Product Code: KNW
• UDI-Device Identifier: 00886333224074
• UDI-Public: 00886333224074
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2025
• Device Model Number: 370-1080-03
• Device Catalogue Number: 370-1080-03
• Device Lot Number: 11454376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown