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	Laceration(s) (1946)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
2 devices in the same lot collected longer sample than the set throw length.Most recent occurrence was set to 2.3cm and collected 4cm samples.Doctor set the length on the exact notch and not in between.
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
2 devices in the same lot collected longer sample than the set throw length.Most recent occurrence was set to 2.3cm and collected 4cm samples.Doctor set the length on the exact notch and not in between.
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.There was no photographic or physical evidence provided which would have allowed for the allegation to be reviewed.However, this defect is a known defect so the complaint is confirmed.This defect is caused by a sticky throw adjustor that makes it difficult to properly place the adjustor into the detents of the body, resulting in it having the possibility to jump forward when fired.An investigation into the sticky throw adjustor found that the most probable cause is an inadequate coating of teflon on the component, resulting in a significant increase of friction between the adjustor and the housing of the device.If the device is returned at a later date, the complaint will be reopened and reinvestigated for assured accuracy.The operational procedure outlining the assembly of the biopince ultra devices was updated to develop a more robust teflon coating and final inspection process for the completed units.Training was provided to the operators to ensure proper adherence to the relevant procedure.

• 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: 15410910
• Report Number: 0001625425-2022-01087
• Device Sequence Number: 5652554
• Product Code: KNW
• UDI-Device Identifier: 00886333224005
• UDI-Public: 00886333224005
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/03/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2025
• Device Model Number: 360-1080-02
• Device Catalogue Number: 360-1080-02
• Device Lot Number: 11430598
• Was Device Available for Evaluation?: No
• 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: 08/31/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 11/04/2022
• 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