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

Model Number	360-1580-03
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Bpu ¿misfired while in patients body.".
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.
Additional Manufacturer Narrative
New information was provided to argon.According to new information, device failed to collect sample and did not misfire in the patient's body.There were no patient injury.Thus this event is no longer reportable.Manufacturer will continue to investigate the returned sample.If new information becomes available related to this complaint, a follow-up report will be submitted.H3 other text : according to new information this event is no longer reportable, manufacturer will continue investigation.
Event or Problem Description
Bpu ¿misfired while in patient's body¿.

• 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: 15313094
• Report Number: 0001625425-2022-01078
• Device Sequence Number: 20200517
• Product Code: KNW
• UDI-Device Identifier: 00886333224036
• UDI-Public: 00886333224036
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 09/26/2022

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 Expiration Date: 05/05/2025
• Device Model Number: 360-1580-03
• Device Catalogue Number: 360-1580-03
• Device Lot Number: 11420357
• 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: 08/15/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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