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

Model Number	360-1080-02
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
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
Physician reports that during a procedure with 1 unit; after ensuring the placement of the lead in the intermediate position (2.4 cm), when firing it is seen that the actual lead inside the patient has turned out to be 3.4 cm.When the position is checked, it is seen that it has changed itself to the position of maximum length.The hospital says that it is a serious incident that could have caused serious damage to the integrity of the patient.Used unit is sent in a double bag, for review at argon.They need a letter explaining the root cause of the incidents.
Event or Problem Description
Physician reports that during a procedure with 1 unit; after ensuring the placement of the lead in the intermediate position (2.4 cm), when firing it is seen that the actual lead inside the patient has turned out to be 3.4 cm.When the position is checked, it is seen that it has changed itself to the position of maximum length.The hospital says that it is a serious incident that could have caused serious damage to the integrity of the patient.Used unit is sent in a double bag, for review at argon.They need a letter explaining the root cause of the incidents.
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
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.One opened sample was returned from the customer for review.A visual inspection was performed on the returned product.The device fired perfectly fine in all three stroke lengths without any automatic change of stroke length adjuster.This can only happen when the adjuster is not completely aligned properly and in between two positions.Since the most likely cause for the automatic change in stroke length adjuster is related to an event within the user's environment and not a manufacturing issue, no corrective action can be implemented at this time.
Event or Problem Description
Physician reports that during a procedure with 1 unit; after ensuring the placement of the lead in the intermediate position (2.4 cm), when firing it is seen that the actual lead inside the patient has turned out to be 3.4 cm.When the position is checked, it is seen that it has changed itself to the position of maximum length.The hospital says that it is a serious incident that could have caused serious damage to the integrity of the patient.Used unit is sent in a double bag, for review at argon.They need a letter explaining the root cause of the incidents.

• 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: 16458369
• Report Number: 0001625425-2023-00984
• Device Sequence Number: 19436840
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2025
• Device Model Number: 360-1080-02
• Device Catalogue Number: 360-1080-02
• Device Lot Number: 11418104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 02/21/2023; 02/21/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 04/06/2023; 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown